Big Pharma Bankrupting US Health Care System

[Guest guest]

SSRI-Research@

Thu, 31 Aug 2006 20:14:30 -0400

[sSRI-Research] Pringle - Big Pharma Bankrupting US Health

Care System

 

 

 

 

Big Pharma Bankrupting US Health Care System

 

http://www.lawyersa ndsettlements. com/articles/ big_Pharma_ bankrupt.

html

August 29, 2006.

By *Evelyn Pringle**

*

*Big Pharma is bankrupting the nation's health care system by

convincing prescribing doctors to over-medicate patients with

expensive psychiatric drugs and then send the bills to government

programs like Medicaid and Medicare.

*

The peddling of the new generation of psychiatric drugs that include

the selective serotonin reuptake inhibitors antidepressants (SSRIs),

and atypical antipsychotics that began arriving on the market in the

late 1980s, has become a cottage industry in the US.

 

Between 1986 and 2004, the sale of antidepressants went from $240

million to $11.2 billion and the sale of anti- psychotic drugs rose

from $263 million in 1986 to $8.6 billion in 2004.

 

These two classes of drugs combined went from $500 million to nearly

$20 billion in 2004, which translates to a 40-fold increase,

according to award winning journalist, Robert Whitaker, author of

Mad In America.

 

A University of Georgia study published in the June 2006 issue of

Journal of Clinical Psychiatry, found that three-quarters of people

prescribed antidepressant drugs receive the medications for a reason

not approved by the federal FDA.

 

The researchers reviewed records on drugs prescribed to 107,000

Georgia Medicaid recipients in 2001. The researchers used Medicaid

data because it is comprehensive and easily accessible, and said the

results are likely to be comparable in other states.

 

The study examined rates of off-label prescribing for drugs that act

on the central nervous system and found that 75% of antidepressant

recipients and 64% of antipsychotic recipients these received the

drugs off-label.

 

While study authors Dr Hua Chen and Professor Jack Fincham

acknowledged that there are legitimate uses for off-label

prescribing, they said that in many cases doctors write off-label

prescriptions based on limited or anecdotal evidence.

 

" Most off-label drug mentions have little or no scientific support, "

said study co-author Jack Fincham, Professor of Pharmacy Care at the

University of Georgia College of Pharmacy to Doctor's Guide News on

July 25, 2006. " And when I say most, " he said, " it's like 70% to 75%. "

 

" Many patients, " he noted, " have no idea that this goes on and just

assume that the physician is writing a prescription for their

indication. "

 

" Physicians have the right to prescribe any medication off label, "

Dr Chen said, " but they also have the responsibility to inform

patients that this medication is being used off label. "

 

Study leader, Dr Chen, an assistant professor at the University of

Houston, said the findings reveal a significant gap in the nation's

drug safety system. The FDA approval process is widely regarded as

the world's most rigorous, she noted, but said off-label prescribing

regularly exposes consumers to drugs that are untested for their

condition.

 

" There's a big gap between this very strict approval process and

this very liberal utilization practice, " Chen said. " Something must

be done to fill this gap. "

 

Professor Fincham, author of the book, " Taking Your Medicine: A

Guide to Medication Regimens and Compliance for Patients and

Caregivers, " told Doctor's Guide that considering the aging

population and the increasing likelihood of off-label prescribing

with age, the number of people receiving off-label drugs will likely

increase in the coming years.

 

According to Dr Chen and Professor Fincham, the off-label use of

central nervous system drugs can account from anywhere from 25% to

80% of a drug's annual sales.

 

Drug makers have found ways to influence prescribers who tend to the

elderly in nursing homes to funnel Medicare funds to Big Pharma

through senior citizens. In one 2003 study published in the Archives

of Internal Medicine, researchers found that 75% of long-term care

elderly residents were receiving psychotropic medications.

 

Another study published in the August 2004 Archives of Internal

Medicine, noted that 41% of prescriptions, for 765,423 people over

age 65, were for psychotropic medications.

 

A more recent June 13, 2005, study in the Archives examined the

quality of antipsychotic prescriptions in nursing home for

approximately 2.5 million Medicaid beneficiaries and found that

" over half (58.2%), " received drugs that exceeded the maximum

recommended dosage, received duplicate therapy, or under the

guidelines, had inappropriate conditions for the medications to

begin with. The study determined that more than 200,000 residents

received antipsychotic therapy but had " no appropriate indications

for use. "

 

On April 11, 2005, the FDA may have plugged a hole in the dike for

the river of Medicare funding flowing from the nursing home industry

when it announced that elderly patients with dementia who were given

antipsychotic drugs were far more likely to die prematurely than

those given placebos and also announced the addition of black box

warnings about the increased risk of death on the labels of Zyprexa

(Eli Lilly) Risperdal (Johnson & Johnson) Abilify (Bristol-Myers

Squibb), Clozril (Novartis), and Geodon (Pfizer).

 

On May 1, 2006, the London Free Press reported a study by Toronto's

Institute for Clinical Evaluative Sciences that showed seniors who

were prescribed the new SSRIs such as Prozac, Paxil and Zoloft were

nearly 5 times more likely to commit suicide during the first month

on the drugs than those patients given the older class of

medications used to treat depression.

 

In conducting the study, the researchers used Ontario coroners'

reports, prescription records and hospital data, and identified

1,142 suicides among older Ontarians, 66 and up, from 1992 to 2000,

and determined whether they had been prescribed antidepressants in

the 6 months before their deaths.

 

Among those patients who were, the risk of suicide in the first

month for those taking an SSRI was nearly 5 times higher than for

patients on the older antidepressants, such as Elavil.

 

The study also found that SSRIs were associated with more violent

means of committing suicide, such as the use of firearms, or jumping

from heights and hanging, Dr David Juurlink, the study's lead author

told the London Free Press.

 

While studies have found an increased risk of suicidal thoughts and

behaviors among children taking SSRIs, up until now, little research

has been done on their link to suicide in aging patients.

 

Big Pharma has found ways to influence doctors within the Veteran

Administration' s hospital system to convince them to prescribe the

new expensive psychiatric drugs rather than the older, cheaper and

equally effective medications.

 

Dr Robert Rosenheck, a Director with the Department of Veterans

Affairs, reviewed the prescribing records for schizophrenic patients

in the VA system and found that more than 80% are now on the new

antipsychotics.

 

In 2003, he calculated that the VA spent more than $208 million on

antipsychotic drugs, with over $106 million going for Zyprexa alone.

 

A government funded study conducted by the National Institute of

Mental Health compared four new generation antipsychotics against an

older medication, perphenazine and only one, Zyprexa, worked any

better at all, and then the difference was minimal.

 

However, Zyprexa also carried the most serious risk of side effects

and was found to be far more likely to cause severe weight gain and

diabetes than the other drugs. The NIMH study also determined that

over 18 months, nearly 75% of the patients had quit taking their

assigned drugs, signaling a high level of dissatisfaction with the

medications.

 

According to the November 24, 2005, Providence Journal, the four new

antiphychotics studied soak up about $10 billion a year, depending

on the dosage, and can cost up to 10 times more than the older

generic and the Medicaid population alone spends an estimated $3

billion a year for these antipsychotic medications.

 

Big Pharma has known that the new antipsychotics were ineffective

for years. A review of 52 studies involving 12,649 patients

published in the December 2000 British Journal of Psychiatry

reported: " There is no clear evidence that the atypical

antipsychotics are more effective or better tolerated than

conventional antipsychotics. "

 

In 2003, an outright bribery scheme was discovered at a hospital in

Massachusetts where doctors were found to have changed the

medication of 4 patients for non-medical reasons. The November 10,

2003, Boston Globe, reported that the patients were switched to

Risperdal, without consent or medical necessity, to make them

eligible for a clinical trial sponsored by Janssen Pharmaceuticals.

 

After uninvolved staff members complained, the situation was

investigated and the trial was stopped. As a result, all state

hospital doctors were required to undergo re-certification in the

ethics of medical research and the hospital's director, Dr Douglas

Hughes, resigned after it was revealed that in the same year, he had

received $30,000 in speaker's fees from Janssen.

 

In recent years the nation's children have become a major target for

the pharmaceutical industry. The new antipsychotics are not approved

to treat any condition in children but studies of children in

Medicaid programs and HMOs have found a drastic increase in the use

of the drugs with children, particularly for behavioral disorders,

according to research published in the March/April 2006 Journal of

Ambulatory Pediatrics.

 

Researchers lead by Dr William Cooper at Vanderbilt University in

Nashville, TN, evaluated data drawn from the National Ambulatory

Medical Care Survey and the National Hospital Ambulatory Medical

Care Survey, which are national samples of health care services

rendered to the US population and conducted by the National Center

for Health Statistics.

 

Between 1995-2002, the study found that there were 5,762,193

outpatient visits to health care providers by children between the

ages of 2-18 years-old, during which an antipsychotic was prescribed.

 

The study shows that Big Pharma has doctors in every setting

prescribing these drugs to kids. Nearly 80% of the visits occurred

in physician's offices, 14% in outpatient clinics, and 9% occurred

in emergency departments. According to the study, 32% of the nearly

6 million prescriptions were written during visits to pediatricians,

family physicians, emergency department physicians, or other types

of providers.

 

According to Doctor Cooper, these antipsychotic medications have

been studied in only a few controlled trials in children, and have

not been studied at all for many behavioral diagnoses. But yet, the

most common diagnosis for children prescribed an antipsychotic was

attention deficit hyperactivity disorder or conduct disorder,

accounting for 29.0% of all antipsychotic visits.

 

Affective disorders such as bipolar disorder or depression accounted

for 23.6% of the visits so that together, behavioral and affective

disorders represented more than half of the prescriptions during the

study period. According to the authors, there is no evidence from

controlled studies that supports the use of antipsychotics for

behavioral conditions.

 

The report states that over 50% of the prescriptions were for a

diagnosis for which antipsychotics have not been studied in children

and that there is little recognized benefits to these medications in

many of the children receiving them.

 

" Thus, " the report notes, " the increasing prescribing of

antipsychotic medications in children for behavioral indications is

concerning given the paucity of information on the overall benefits

and risks of this class of medications in children. "

 

A finding in the study that demonstrates the ability of Big Pharma

to successfully market drugs off-label to children is that the

increased prescribing of antipsychotics for behavioral disorders

coincided with the introduction of new atypical antipsychotic

medications.

 

The study also explained that there has been no increase in mental

health disorders such as schizophrenia that would account for the

increases " as recent studies do not suggest significant increases in

the incidence of schizophrenia, " it concluded.

 

" In addition, " the researchers explained, " schizophrenia and

psychosis accounted for only 13.5% of the total antipsychotic visits

during the study period, so this diagnosis alone could not explain

the increase. "

 

" Therefore, the most likely explanation for the study results is

that similar to our findings in the Tennessee Medicaid population, "

the authors said, " there was a substantial increase in physician

prescribing of antipsychotics during the study period. "

 

The mass drugging of children on Medicaid is happening all over the

country. In 2001, psychiatrist, Dr Stefan Kruszewski, was hired to

review psychiatric care provided by government-funded agencies in

Pennsylvania to identify fraud, waste, and abuse, and found cases of

what he refers to as " insane polypharmacy, " where children were

placed in state-run treatment facilities and over-medicated with the

new antipsychotics and anticonvulsants sometimes for years.

 

Over the past decade since the new antipsychotics came on the

market, they have been linked to serious side effects, that include

the risk of substantial weight gain, diabetes, and cardiac

dysrythmias, and according to Dr Copper's report, preliminary

studies suggest that side effects may occur more commonly and be

more severe in children than in adults.

 

This assertion is proving to be true. The Children's Hospital of

Philadelphia recently found that 19% of newly diagnosed Type 2

diabetic children were being treated with the new antipsychotic

drugs, all of which are now required to carry a black box warning to

alert doctors about the dangers of diabetes associated with the drugs.

 

A recent analysis by USA TODAY of the FDA adverse event reporting

system between 2000 and 2004, found at least 45 deaths of children

where the " primary suspect " was an atypical antipsychotic. USA also

discovered more than 1,300 cases of serious side effects, including

some that were life threatening, such as convulsions and a low white

blood cell count.

 

However, critics of regulatory officials are quick to point out that

the FDA has known about the dangers of these drugs long before now.

For instance, in the fall of 2001, a paper published in the Journal

of Clinical Psychiatry said the FDA had been alerted to 19 cases of

diabetes associated with Zyprexa and one patient died.

 

Of the 19 patients, the paper said, seven had newly diagnosed

hyperglycemia and in 2 cases, the sugar disorder developed within

one week of taking Zyprexa, and developed within six months for the

other 8 patients.

 

The most studied adverse effect has been their association with

hyperglycemia, in some cases leading to ketoacidosis, coma, or

death. But nonetheless, even though Risperdal was recently refused

FDA approval for treating autism, this class of drugs are

increasingly being used off-label to treat behavior problems in

children on the autism spectrum.

 

As for treating children who are diagnosed with schizophrenia, the

results of a study published in August 2006, by the New York

Psychiatric Institute found that the older antipsychotics work much

better than the new. The average response rate in children to

medication among 8 studies employing the new antipsychotics was

55.7%, compared to a 72.3% response rate among children in 13

studies employing older drugs.

 

The study also found that the average weight gain in patients

treated with the older drugs was much lowers and the sedation side

effect was more common with the new drugs. The authors noted that

the FDA " has not approved any antipsychotic drugs for treating

childhood schizophrenia; yet, clinicians routinely use medications

for this disorder. "

 

However, there are signs that Big Pharma's ability to use children

as funnels to drain tax dollars from government health care programs

might be waning. On August 16, 2006, the Houston Chronicle reported

that 5 doctors who treat poor children in Texas were notified that

they need to return Medicaid money used to pay for psychiatric drugs

to that state.

 

This latest move, newspaper said, is part of a 2-year effort to

better regulate how children on Medicaid are prescribed psychiatric

drugs.

 

Two years ago, Brian Flood, the Texas Health and Human Services'

Inspector General, and Texas Comptroller Carole Keeton Strayhorn,

began reviewing information on how doctors were prescribing

stimulants, antidepressants and antipsychotics to children on Medicaid.

 

The studies revealed that children were being prescribed multiple

psychiatric drugs and some children as young as 3 were taking the

mood-altering medications.

 

Ms Strayhorn's study found a case where one child had 14

prescriptions for 11 different medications, at a cost of $1,088 a month.

 

Mr Flood's review of a two-month period of Medicaid records

determined that 63,118 children were on stimulants, antidepressants

or antipsychotics, with nearly one-third of the kids taking drugs

from more than one of the 3 classes of drugs at the same time.

 

The review of records found that doctors had filed 114,315 claims

amounting to more than $17 million for the children.

 

As a result of the studies, last year, the Texas Health and Human

Services Commission established strict guidelines for prescribing

psychiatric drugs for children on Medicaid and the state has seen a

dramatic reduction in multiple prescriptions.

 

The really good news is that a great number of Texas children are

apparently cured of their mental illnesses because an analysis of

the data taken last year shows that within 5 months after the new

rules were in place, the number of foster care children prescribed

five or more psychiatric drugs fell by 31%.

 

There are about 1.9 million Texas children on Medicaid, according to

the Chronicle.

 

Many states are going after the drug makers to retrieve the money

spent on illegal off-label prescriptions. In July, 2006, Mississippi

filed a lawsuit against Eli Lilly with allegations that the company

improperly marketed Zyprexa for " off-label " uses and defrauded the

state Medicaid program out of millions of dollars, according to the

July 27, 2006, Jackson Clarion Ledger.

 

The lawsuit alleges that Lilly sales representatives convinced

Mississippi doctors to prescribe the Zyprexa to patients who

suffered from anxiety, mood swings and disturbed sleep when the drug

was only FDA approved for the treatment of adults with bipolar

disorder or schizophrenia.

 

The suit also alleges that Lilly did not properly emphasize the

dangers of the drug, such as an increased risk of diabetes, and that

treating Medicaid patients who became ill from the drug has

increased Medicaid costs.

 

Experts in the medical profession who have not been compromised by

the drug companies are furious over the practice of drugging kids

with dangerous psychiatric drugs for profit.

 

For instance, Pediatrician, Dr Lawrence Diller, author of the book,

" Should I Medicate My Child, " testified before an FDA advisory

committee in September 2004, on the rampant off-label prescribing of

SSRI drugs to children after learning about 8 previously undisclosed

studies that proved the drug makers knew all the long that SSRIs

were linked to suicide in children but kept the findings hidden from

doctors who were prescribing the drugs.

 

Dr Diller said the " final blow " was learning of these 8 studies and

that the loss of credibility within the medical profession extended

beyond psychiatry into all of medicine and ended his testimony by

stating:

 

" The blame is clear: The money, power and influence of the

pharmaceutical industry corrupt all. The pervasive control that the

drug companies have over medial research, publications, professional

organizations, doctors' practices, Congress, and yes, even agencies

like the FDA, is the American equivalent of a drug cartel. "