ig 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 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."