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Monday, August 5, 2013

Drugs might breed violence

Attacks on staff rise at Western State Hospital

M. ALEXANDER OTTO; The News Tribune
Last updated: May 28th, 2007 02:48 PM (PDT)

Violence has been a growing problem at Western State Hospital for
years.
If present trends continue, one in four of the Lakewood mental
hospital's more than 1,700 workers can expect to be assaulted by a patient
in 2007, according to the state Department of Labor and Industries.

For years, hospital administrators have blamed the violence on
familiar causes: not enough staff members, not enough money and increased
societal violence that leads to the admission of more-violent patients. But
they don't have the data to back up those assertions.

A News Tribune analysis of drug-prescribing trends at Western since
1999 finds another possible factor: Western is giving more patients
psychiatric drugs with side effects that can include extreme agitation and
aggression.

The drugs include newer antidepressants and newer anti-psychotics
dubbed atypical anti-psychotics.

The newer drugs, which are expensive compared with older, generic
alternatives, have been heavily promoted at the hospital by the
pharmaceutical companies that make them. Sales representatives for those
companies have logged about 1,200 visits to Western since late 2003, when
administrators began tracking their activity.

Concerned about their influence on prescribing patterns, the hospital
in March banned all drug company representatives from visiting the campus to
meet with doctors.

Randy Burkholder, an associate vice president for Pharmaceutical
Research and Manufacturers of America, the Washington, D.C.-based drug
industry lobby group, acknowledged The News Tribune analysis, saying it's a
"great idea" to discover more about the impact of pharmaceuticals through
original investigation.

"There may be something there, there may not be," he said about the
findings. But he cautioned that the analysis doesn't prove cause and effect.
Instead, it just hints at a possible association. Only additional research
can make that determination, Burkholder said.

The link between changes in drug use at Western and recent increases
in violence "is very plausible," said Dr. Stefan Kruszewski, a
Harvard-trained psychiatrist and an expert on the side effects of
anti-psychotic drugs who is on the faculty at Eastern University, outside
Philadelphia.

"There is a significant relationship between restlessness and
agitation induced by medicine and the propensity for violence," Kruszewski
said.

Western has never studied the idea that changes in drug use could
contribute to increased violence, said Dr. Roger Jackson, the hospital's
acting medical director and an employee there since 1993.

Western is not alone in that regard.

"This has not been adequately studied" at any psychiatric hospital,
Kruszewski said. "Most studies done on (psychiatric) violence assume
violence is secondary to the illness or the surroundings, or because of lack
of staff, money or social structures."

Those assumptions, which have dominated internal and state agency
violence studies at Western for more than a decade, do not hold up under
analysis.

Since 1999, the staffing ratio of ward workers to patients has
improved from 1.18 workers for every patient to 1.34 workers per patient in
2006.

Funding has increased about 50 percent overall - going from $106
million in 1999 to $156 million in 2007 - and has kept pace with medical
inflation.

Hospital administrators don't offer statistical evidence that society
has become more violent, leading to a more violent patient population.
Meanwhile, violent crime in the areas from which Western draws its patients
has dropped significantly, according to U.S. Department of Justice
statistics.

What does correspond with the increase in violence is the roughly 35
percent increase since 1999 in the use of drugs that a hospital pharmacy
handbook and drug experts say are more likely than similar medications to
induce agitation and aggression, The News Tribune analysis indicates.

By the end of 2006, there was roughly one order for these drugs for
every patient at Western.


NEW DRUGS, MORE DRUGS


Drug therapy has been the mainstay of psychiatric treatment for
decades, and it long has been known that while some medications can make
patients drowsy, others can cause extreme agitation and a tendency to lash
out.

This restlessness can be physical, mental or both, and is known as
akathisia.

"It's almost like having too many cups of coffee in the morning," said
Dr. Neil Kaye, a psychiatrist and an authority on the condition, as well as
a professor at Jefferson Medical College in Philadelphia. "It's extremely
uncomfortable and makes people have a shorter fuse."

Akathisia "is horrendous," said Lori Yates, a Western social worker
who once was a mental patient in a Texas hospital before her illness was
brought under control.

She knows the side effect well, because she had to try several drugs
before the right ones were found to help her.

"There's agitation, hyperarousal, sleeplessness - your psychosis gets
worse," Yates said.

Starting in the mid-1990s, new atypical anti-psychotics came onto the
market to treat schizophrenia and related disorders, the most common
diagnoses at Western. Currently, there are seven atypical anti-psychotic
drugs, three of them new since 2001.

They are expensive, some more than $15 per pill, compared with less
than a dollar per pill for the older medications. In 2006, the hospital
spent more than $5 million on atypical anti-psychotics, according to
Western's
pharmacy.

Promoted by drug companies as safer and more effective, atypicals are
widely used at Western and most psychiatric hospitals.

Their growing use, coupled with the continued use of some of the older
drugs, has resulted in an increase since 1999 of about 30 percent in the
amount of anti-psychotic medication being given to patients at Western, The
News Tribune found.

Many patients now receive two or more anti-psychotic drugs at once, a
doubling of medication unheard of just eight years ago, when the older drugs
were more prevalent.

Jackson, the acting medical director, attributed the increased use of
anti-psychotics to several factors. In some cases, he said, disappointing
results with one drug led physicians to add a second drug.

And compared with 1999, he said, a greater proportion of patients at
Western have schizophrenia and require anti-psychotic drugs.

But there also has "been a very hard sell on the (newer drugs), and a
very clever hard sell" to psychiatrists and other doctors worldwide, said
Dr. David Healy, a professor of psychiatry at the University of Wales and an
internationally recognized authority on psychiatric drug side effects.

Recently, several major medical studies have cast doubt on claims that
the newer anti-psychotic drugs are more effective and safer than the
typicals.

A British study published last fall by the American Medical
Association found that patients did as well or better on the older drugs.
Another suggested patients who take the newer drugs could be more likely to
develop diabetes and die at an earlier age.

The sales pitches, Healy said, have led the medical community to
"assume the evidence is there" to back up the advertising claims.

But the evidence, he said, "just is not there."

Medical staff at Western said they are aware of the situation, and are
rethinking their use of atypicals.

"It is not yet clear to me what will eventually happen with regard to
prescribing practices," said Jackson, "because the newer drugs are still
believed to have some benefits, despite the recent findings.

"The jury is still out."

Burkholder, the drug industry executive, acknowledged the recent
findings concerning atypicals, and said the studies should "help doctors
tailor treatment to the individual patient."


ASSUMPTIONS QUESTIONED


Akathisia once was thought to be an uncommon side effect with the
newer anti-psychotics, but for three of the atypicals in common use at
Western, that's now in doubt.

Bristol-Myer Squibb's atypical drug is called Abilify, which hit the
market in 2002. Data from the company suggested up to 15 percent of people
who took the drug developed akathisia.

Recent studies suggest a higher percentage. Possibly the highest
estimate to date came from a small study published in March. Researchers
found that five of 12 patients, or 42 percent, developed akathisia after
taking Abilify.

At the beginning of December, about one in 10 Western patients
received Abilify, according to The News Tribune analysis.

Bristol-Myer Squibb spokesman David Rosen defended his company's
product by pointing out that the small number of patients in the recent
Abilify study might have skewed the results.

Despite recent findings, many doctors still assume that atypicals are
not likely to cause akathisia, Jackson said, "so their index of suspicion is
not as high."

That could be part of the reason, he said, for a roughly 50 percent
drop at Western over the past eight years in the use of drugs - such as
tranquilizers and propranolol, a beta blocker drug also used for heart
problems - used to control drug-induced anxiety and agitation.

The pharmacy periodically prints out lists of drug orders, giving a
snapshot of drug trends at Western.

A printout on Nov. 24, 1998, showed 1,736 orders for drugs often used
to calm patients experiencing akathisia, among about 913 patients at the
hospital. On Dec. 6, 2006, the most recent day for which data were
available, there were 792 orders for those drugs among 860 patients.


FDA ORDERS LABEL WARNINGS


Western State Hospital also has switched to newer types of
antidepressants, including Prozac and similar drugs, that are linked to
akathisia.

Research by the University of Wales' Healy and others suggests the
drugs sometimes cause such extreme agitation that people commit suicide to
escape it or lash out in murderous rage.

The Food and Drug Administration in 2004 required manufacturers to
update the drugs' labels to warn of the possibility of "anxiety, agitation .
hostility (aggressiveness), impulsivity, akathisia" and other problems,
including suicidal behavior.

Pfizer Pharmaceuticals' Zoloft was one of the antidepressants whose
label was updated. There were 74 orders for the drug at Western State
Hospital on a single day, Dec. 6, 2006.


POSSIBILITY, NOT PROOF


Like Burkholder, the psychiatrists interviewed for this story said The
News Tribune's analysis only suggests that changes in drug use might
contribute to violence at Western. Proving such a link would require an
analysis of patient data not available to the public.

It would be important to analyze incidents of violence to see what
drugs patients were on at the time, as well as their histories of violence
while not medicated, said Kaye, the Philadelphia psychiatrist and professor.

Hospital administrators and state regulators should pursue such an
analysis, said Dr. David Antinucho, a University of Nevada psychiatrist and
an authority on psychiatric drugs. That could lead to a new way to combat
violence not only at Western, but also at psychiatric hospitals across the
nation, he said.

"This should have been done years ago," said Eastern University's
Kruszewski. "There is little information in the psychiatric and
neuropsychiatric literature" analyzing drug use and violence at mental
hospitals.

Proof that drug choice influences violence at Western would be "very
important for everyone to know," Kaye agreed, adding that it could lead to
better training for doctors on how to recognize, observe and treat
akathisia.

After reviewing the findings of The News Tribune analysis, Western
State Hospital chief executive officer Andy Phillips said he would be "very
interested" in studying the matter further, but said the stumbling block
would be finding funding to back such research.


REVOLVING DOOR CLOSES


What stands out in Western's pharmacy data is that doctors, who can
prescribe virtually any anti-psychotic or antidepressant drug they want,
rapidly adopt the newest and most expensive drugs from the pharmaceutical
industry.

Jackson, the hospital's acting medical director, said one likely
reason is that by the time patients come through Western's door, some
already have failed on the older drugs.

But until they were banned from visiting campus in March,
pharmaceutical industry salespeople were a fact of life at Western, as they
are in virtually every hospital and doctor's office in the country.

Western is a huge market for the drug industry, said Phillips.

Since December 2003, sales reps made hundreds of visits a year to
Western to brief doctors about their latest products, according to pharmacy
logs analyzed by The News Tribune.

About 50 sales representatives from 13 companies, many visiting
several times a week, accounted for those visits. Typically, representatives
from a given company visited in pairs or small groups, according to pharmacy
logs.

For many doctors, there was "no appreciation that what they hear from
drug reps (was) a sales pitch," said Jackson, who refuses to see drug
sellers.

From October until the March ban, drug representatives were required
to state how much time they spent on campus. Records show visits lasting
from 15 minutes to more than three hours.

The vast majority of the visits were by representatives from companies
with new antidepressants and atypicals on the market. More than half of the
visits were from companies that make atypicals and antidepressants linked to
higher rates of akathisia, records show.

Representatives often visited the same doctors repeatedly.

Asked why Pfizer representatives has made almost 200 visits to Western
since December 2003, company spokesman Bryant Haskins said, "That's where
our customers are." Pfizer makes the atypical drug Geodon, one of those
linked to agitation.

"At hospitals, we have a number of Pfizer products being used," he
said, "so our sales reps check in regularly to make sure (staff) have new
information, samples, and any questions answered."

Western's ban on drug representatives' visits with doctors comes after
years of increasing restrictions on pharmaceutical promotions. Several years
ago, administrators banned representatives from helping doctors select drugs
for specific patients. And physicians may not accept gifts from
representatives beyond small items such as pens and note pads.

The ban resulted from doctors feeling pressured by sales pitches, said
Dr. Margaret Dean, Western's medical director until May. At weekly medical
review meetings, she said, there sometimes were so many drug sellers that
doctors had hard a time finding chairs.

She and others said sales representatives hung out after the meetings
to pigeonhole doctors.

"That kind of pushy interaction can't happen anymore," Dean said.

Drug companies, however, still buy lunches and dinners and host
lectures at local restaurants for Western doctors and nurses, according to
one physician, who did not want his name in the paper for fear of losing his
job.

http://www.thenewstribune.com/news/local/story/72700.html

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