>
> 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 antipsychotic 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."
>
> Information for injured parties can be found at Lawyers and
>
Settlements.com
>
> evelyn.pringle@
sbcglobal.net
>
> Evelyn Pringle is a columnist for OpEd News and an investigative
> journalist
> focused on exposing corruption in government and corporate America.
>
>
>
>
> --
> NOTICE: This post contains copyrighted material the use of which has not
> always been authorized by the copyright owner. I am making such material
> available to advance understanding of
> political, human rights, democracy, scientific, and social justice issues.
> I
> believe this constitutes a 'fair use' of such copyrighted material as
> provided for in section 107 of the US Copyright
> Law. In accordance with Title 17 U.S.C. Section 107
>
> "A little patience and we shall see the reign of witches pass over, their
> spells dissolve, and the people recovering their true sight, restore their
> government to its true principles. It is true that in the meantime we are
> suffering deeply in spirit,
> and incurring the horrors of a war and long oppressions of enormous public
> debt. But if the game runs sometimes against us at home we must have
> patience till luck turns, and then we shall have an opportunity of winning
> back the principles we have lost, for this is a game where principles are
> at
> stake."
> -Thomas Jefferson
>
>
>
