Does anyone remember Thorazine? It was an antipsychotic given to
mentally ill people, often in institutions, that was so sedating, it
gave rise to the term "Thorazine shuffle." Ads for Thorazine in medical
journals, before drugs were advertised directly to patients, showed Aunt
Hattie in a hospital gown, zoned out but causing no trouble to herself
or anyone else. No wonder Thorazine and related drugs Haldol, Mellaril
and Stelazine were called chemical straitjackets.
But Thorazine and similar drugs became close to obsolete in 1993
when a second generation of antipsychotics which included Risperdal,
Zyprexa, Seroquel, Geodon and Abilify came online. Called "atypical"
antipsychotics, the drugs seemed to have fewer side effects than their
predecessors like dry mouth, constipation and the stigmatizing and
permanent facial tics known as TD or tardive dyskinesia. (In actuality,
they were similar.) More importantly, the drugs were obscenely
expensive: 100 tablets of Seroquel cost as much as $2,000, Zyprexa,
$1,680 and Abilify $1,644.
One drug that is a close cousin of Thorazine, Abilify, is currently the
top-selling of all prescription drugs in the U.S. marketed as a supplement to antidepressant drugs, reports the
Daily Beast. Not
only is it amazing that an antipsychotic is outselling all other drugs,
no one even knows how it works to relieve depression, writes Jay
Michaelson. The standardized United States Product Insert says Abilify's
method of action is "unknown" but it likely "balances" brain's
neurotransmitters. But critics say antipsychotics don’t treat anything
at all, but zone people out and produce oblivion. They also say there is
a concerning rise in the prescription of antipsychotics for routine
complaints like insomnia.
They are right. With new names and prices and despite their unknown
methods of action, Pharma marketers have devised ways to market drugs
like Abilify to the whole population, not just people with severe mental
illness. Only
one percent of the population, after
all, has schizophrenia and only 2.5 percent has bipolar disorder.
Thanks to these marketing ploys, Risperdal was the seventh best-selling
drug in the world until it went off patent and Abilify currently rules.
Here are some of the ways Big Pharma made antipsychotics everyday drugs.
Approval Creep
Everyone has heard of "mission creep." In the pharmaceutical world,
approval creep means getting the FDA to approve a drug for one thing
and pushing a lot of other drug approvals through on the coattails of
the first one. Though the atypical antipsychotics were originally drugs
for schizophrenia, soon there was a dazzling array of new uses.
Seroquel was first approved in 1997 for schizophrenia but
subsequently approved for bipolar disorder, psychiatric conditions in
children and finally as an add-on drug for depression like Abilify. The
depression "market" is so huge, Seroquel's last approval allowed the
former schizophrenia drug to make
$5.3 billion a
year before it went off patent. But before the add-on approval,
AstraZeneca, which makes Seroquel, ran a sleazy campaign to convince
depressed people they were really "bipolar." Ads showed an enraged woman
screaming into the phone, her face contorted, her teeth clenched. Is
this you, asked the ads? Your depression may really be bipolar disorder,
warned the ad.
Sometimes the indication creep is under the radar. After heated FDA
hearings in 2009 about extending Zyprexa, Seroquel and Geodon uses for
kids--Pfizer and AstraZeneca slides showed that kids died in clinical
trials--the uses were added by the FDA but never announced. They were
slipped into the record right before Christmas, when no news breaks, and
recorded as "label changes." Sneaky.
And there is another "creep" which is also under the radar:
"warning creep." As atypical antipsychotics have gone into wide use in
the population, more risks have surfaced. Labels now warn against
death-associated risks in the elderly, children and people with
depression but you have to really read the fine print. (Atypical
antipsychotics are so dangerous in the elderly with dementia, at least
15,000 die in nursing homes from them each year, charged FDA drug
reviewer David Graham in congressional testimony.) The Seroquel label
now warns against cardiovascular risks, which the
FDA denied until the drug was almost off patent.
Dosing Children
Perhaps no drugs but ADHD medications have been so widely used and
often abused in children as atypical antipsychotics. Atypical
antipsychotics are known to "improve" behavior in problem children
across a broad range of diagnoses but at a huge price: A National
Institute of Mental Health study of 119 children ages 8 to 19 found
Risperdal and Zyprexa caused such obesity a
safety panel ordered the children off the drugs.
In only eight weeks, kids on Risperdal gained nine pounds and kids
on Zyprexa gained 13 pounds. "Kids at school were making fun of me,"
said one study participant who put on 35 pounds while taking Risperdal.
Just like the elderly in state care, poor children on Medicaid are
tempting targets for Big Pharma and sleazy operators because they do not
make their own medication decisions. In 2008, the state of
Texas charged Johnson
& Johnson subsidiary Janssen with defrauding the state of millions
with “a sophisticated and fraudulent marketing scheme,” to “secure a
spot for the drug, Risperdal, on the state’s Medicaid preferred drug
list and on controversial medical protocols that determine which drugs
are given to adults and children in state custody.”
Many other states have brought legal action against Big Pharma
including compelling drug makers to pay for the extreme side effects
that develop with the drugs: massive weight gain, blood sugar changes
leading to diabetes and cholesterol problems.
Add-On Conditions
It's called polypharmacy and it is increasingly popular:
Prescribing several drugs, often as a cocktail, that are supposed to do
more than the drugs do alone. Big Pharma likes polypharmacy for two
obvious reasons: drug sales are tripled or quadrupled—and it's not
possible to know if the drugs are working. The problems with
polypharmacy parallel its "benefits." The person can’t know which, if
any, of the drugs are working so they take them all. By the time someone
is on four or more psychiatric drugs, there is a good chance they are
on a government program and we are paying. There is also a good chance
the person is on the
drugs for life, because withdrawal reactions make them think there really is something wrong with them and it is hard to quit the drugs.
Into this lucrative merchandising model came the idea of "add-on" medications and "
treatment-resistant depression." When
someone's antidepressant didn't work, Pharma marketers began floating
the idea that it wasn't that the drugs didn't work; it wasn't that the
person wasn't depressed to begin with but had real life, job and family
problems—it was "treatment-resistant depression." The person needed to
add a second or third drug to their antidepressant, such as Seroquel or
Abilify. Ka-ching.
Lawsuits Don't Stop Unethical Marketing
Just as Big Pharma has camped out in Medicare and Medicaid, living on our tax dollars while
fleeing to England so
it doesn't have to pay taxes, Pharma has also camped out in the
Department of Defense and Veterans Affairs. Arguably, no drugs have been
as good for Big Pharma as atypical antipsychotics within the military.
In 2009, the Pentagon spent $8.6 million on Seroquel and VA spent $125.4
million—almost $30 million more than is spent on a
F/A-18 Hornet.
Risperdal was even bigger in the military. Over a period of nine
years, VA spent $717 million on its generic, risperidone, to treat PTSD
in troops in Afghanistan and Iraq. Yet not only was risperidone not
approved for PTSD, it didn't even work. A 2011 study in the Journal of
the American Medical Association found the drug worked no better than
placebo and the money was totally wasted.
In the last few years, the makers of Risperdal, Seroquel and
Zyprexa have all settled suits claiming illegal or fraudulent marketing.
A year ago, Johnson & Johnson admitted mismarketing Risperdal in a
$2.2 billion settlement.
But the penalty is nothing compared with the $24.2 billion it made from
selling Risperdal between 2003 to 2010 and shareholders didn't blink.
The truth is, there is too much money in hawking atypical antipsychotics
to the general population for Pharma to quit.
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