Study: Newer Antipsychotic Drugs Are Overused

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http://www.webmd.com/mental-health/news/20110107/study-newer-antipsychotic-drugs-are-overused

Study: Newer Antipsychotic Drugs Are Overused

Researchers Say Many Doctors Prescribe

Drugs Despite Lack of Evidence of Effectiveness

By Goodman

WebMD Health News

Reviewed by J. ,

MD

Jan. 7, 2011 -- Many people taking powerful psychiatric medications

that increase their risk of weight gain

and diabetes

are prescribed those drugs when there’s little evidence that

they will get any benefit from them, a new study shows.

What’s more, experts say that even when these drugs, which

are known as atypical antipsychotics, are prescribed as

recommended, they may not be safer or more effective than the

less expensive, older medications that they’ve apparently

replaced.

“Atypical agents were once thought to be safer and possibly

more effective,” says study researcher G. Caleb , MD,

an assistant professor in the department of medicine at the

University of Chicago Hospitals. “And what we’ve learned over

time is that they are not safer, and in the settings where

there’s the best scientific evidence, they are no more

effective.”

How Drugs Developed for Schizophrenia Became Used as

Antidepressants

The first generation of drugs to treat serious mental

illnesses like schizophrenia

were introduced in the late 1950s and 1960s, but those drugs

often had disfiguring and painful neurologic side effects like

muscle

spasms and tremors and caused involuntary movements like

facial grimacing.

In 1989, the first of a newer generation of atypical

antipsychotic drugs, Clozaril, was introduced with the promise

of being more effective than its predecessors, with fewer side

effects. Other medications in the class soon followed,

including Abilify, Geodon, Invega, Risperdal, Saphris,

Seroquel, and Zyprexa.

“Since there were all these new drugs, and it costs 700 to

800 million to bring a drug to market, drug companies needed

to make that money back,” says Lieberman, MD, chairman

of the department of psychiatry

at Columbia University, who was not involved in the study.

“These drugs were marketed aggressively.”

The study, which was published online in the journal Pharmacoepidemiology

and Drug Safety, documents what Lieberman and others

believe were the effects of that marketing.

Researchers found that the number of office visits in which a

doctor documented a patient’s use of atypical antipsychotics

more than doubled since the mid-1990s -- climbing from 6.2

million in 1995 to 14.3 million by 2008, making them the

top-selling pharmaceutical drug class.

Over time, the way doctors prescribed those drugs changed,

too, with doctors becoming more likely to prescribe these

powerful medications for conditions in which they had not been

rigorously studied or FDA approved, such as anxiety, depression,

attention

deficit disorder, and for aggression and agitation in

dementia patients.

In adults, for example, the use of any antipsychotic

medication -- old or new -- remained relatively stable from

1995 to 2001. But from 2001 to 2006 use of the medications

doubled, the study showed, indicating that doctors were

becoming quicker to turn to these powerful drugs.

In children, the use of the drugs skyrocketed, increasing

800% from 1995 to 2005.

“Time and time again what we see is medications that are

prematurely adopted in populations that have little or nothing

to gain, and this study is yet another example of how both

doctors and patients may overenthusiastically or prematurely

adopt medicines beyond the evidence base,” says.

Atypical Antipsychotics Become a Target of Lawsuits

In many cases, government regulators felt that

pharmaceutical companies promoting these drugs broke the

law by encouraging doctors to prescribe them “off-label.”

Off-label drugs are those prescribed by doctors for

purposes not approved by the FDA.

According to a report released in December 2010 by the

consumer watchdog Public Citizen, some of the largest drug

company settlements with the federal government in the

last two decades were for the unlawful promotion of

atypical antipsychotic drugs.

In 2010, for example, the drug company AstraZeneca paid

$520 million to settle allegations by the federal

government that it engaged in unlawful promotion of its

drug Seroquel, which is the top-selling atypical

antipsychotic.

AstraZeneca Responds

AstraZeneca offered the following written response to the

findings of the new study:

“AstraZeneca believes that Seroquel is a safe and

effective medication when used as recommended in the

prescribing information and offers clinicians, patients

and their loved ones an important treatment option.

Doctors need a range of options as they seek an

appropriate treatment for individual patients, because

they recognize a one-size-fits-all approach to treating

all people with mental illnesses like bipolar

disorder and schizophrenia is not possible.Doctors

consider the needs of individual patients and the array of

treatments that are available, including prescription

medicines. Doctors are trained to carefully make these

choices.

The company has worked diligently with the FDA to ensure

that the safety profile of Seroquel is reflected

appropriately in the prescribing information so that

health care professionals can weigh the risk and benefit

of Seroquel when making treatment decisions.

It is AstraZeneca’s policy to promote our medicines and

to conduct interactions with healthcare professionals in

compliance with the laws and regulations that govern the

healthcare community in the United States. We train

AstraZeneca employees to follow our compliance policies.”

Putting the Brakes on Inappropriate Use

Experts feel the overuse of these medications will need

to be addressed on several fronts.

“There are several strategies that can be used to achieve

more rational use of these and other psychotropic

medicines, including patient and physician education, FDA

empowerment, and denial of payments by public and private

payers for uses that lack sufficient scientific evidence,”

says.

Lieberman said more comparative effectiveness studies

would help doctors better understand when drugs in the

atypical antipsychotic class were superior to each other

or to older drugs, and that would better inform

prescribing practices.

“It’s a bit like going to the supermarket and trying to

buy laundry detergent: This one has enzymes; this one has

brighteners.” he says. “But we don’t really know how the

drugs compare to each other.”

Many felt that the solution should not include preventing

doctors from being able to prescribe drugs off-label.

“Off-label prescribing is an important component of

practice,” Lieberman says. “The reason is that it

really takes a lot of money for a drug company to jump

through all the hoops to get an FDA indication. There

may be good evidence that a drug is effective in a

given condition, but the company doesn’t see enough of

a market there to get it approved.”

But he admits that many doctors may be using too free

a hand with the prescription pad.

“On the other hand, you don’t want to be promiscuous

and abuse that privilege,” he says.