For instance, Seroquel, marketed by AstraZeneca, is only FDA approved to treat acute manic episodes associated with bipolar I disorder and schizophrenia, and yet it is one of the most widely prescribed drugs in the world.
Astra reports that over 16 million patients have taken Seroquel since it came on the market in 1997, and the drug had sales of close to three and a half billion dollars in 2006, according to SEC filings.
Decision Resources, an advisory firm on health care matters, reported that in 2005, two of the top 10 selling drugs worldwide were atypicals.
A new study by the US Agency for Healthcare Research and Quality, found that between 1997 and 2004, spending on antipsychotics more than tripled from $1.3 billion to $4.1 billion and the largest purchasers of atypicals are public health care programs.
The other drugs in this class include Eli Lilly's Zyprexa, Bristol-Myers Squibb's Abilify, Johnson & Johnson's Risperdal, and Pfizer's Geodon.
These drugs were promoted as working better than the old "typical" antipsychotics in addition to having fewer of the serious side effects associated with the older drugs. Both of these claims have now been proven false, but unfortunately tens of millions of people have already taken the new drugs.
A study funded by the National Institute of Mental Health, entitled the "Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)," compared the atypicals against the older medication, perphenazine and found the atypicals were no more effective than the older drug although they cost 10 to 20 times more. By comparison, the cost of perphenazine was $50 a month, and Zyprexa was $545.
But the results of this $40-odd million dollar tax payer funded study is not news. Back in December 2000, the British Journal of Psychiatry reported a review of 52 studies involving 12,649 patients and stated: "There is no clear evidence that the atypical antipsychotics are more effective or better tolerated than conventional antipsychotics."
Over the past several years, studies have linked the atypicals to a number of serious health problems including insulin resistance and diabetes. According to an October 2006, report by the National Association of State Mental Health Program Directors, diabetes causes tissue damage in many organs, is a major cause of vascular disease, and is the number one cause of adult blindness, end-stage kidney disease and non-traumatic amputations.Insulin resistance, the report says, is closely linked to developing metabolic syndrome, which includes hypertension, high cholesterol, increased blood clotting and eventually insulin dependent diabetes.
Astra is currently facing nearly 10,000 lawsuits in state and Federal courts over injuries and deaths caused by Seroquel, and Eli Lilly has already agreed to pay well over a $1 billion to settle cases out-of-court with approximately 26,000 Zyprexa victims.
In February 2007, the state of Pennsylvania filed a lawsuit against AstraZeneca, and other atypical makers, alleging the drug giant illegally marketed Seroquel off-label for unapproved uses.
The state is demanding reimbursement for the cost of the drug and medical care provided to patients who developed serious health conditions while taking the drug. The lawsuit alleges Astra concealed the risks of Seroquel and exaggerated the benefits while persuading doctors to prescribe it for uses not FDA approved as safe and effective.
Astra, the complaint alleges, cost Pennsylvania's Medicaid and drug assistance for the elderly program millions of dollars for "reimbursing for non-medically accepted indications and non-medically necessary uses," of Seroquel, as well as "significant sums of money for the care and treatment" of patients injured by the drug.
Legal experts say millions of people have been duped into taking the atypicals with massive off-label marketing campaigns based on lies, distortions, and rigged-for-profit clinical trials.
Attorney, Derek Braslow, of the Conshohocken, Pennsylvania law firm, Pogust & Braslow, says the schemes usually follow a familiar pattern. "First," he explains, "the drug maker promotes the drug as significantly more effective than the current standard of care when in reality, its effectiveness is questionable."
"Second," he says, "they market the drug to doctors as safer when not enough studies have been conducted to determine whether it is safe and perhaps, the studies were designed in a way that would never detect the risk in the first place."
"Third," Mr Braslow notes, "the companies promote the drug off label for all types of indications and for all age groups."
But prescribing doctors have played a major role in medicating patients for profit with the new atypicals. Drug companies are prohibited from promoting a drug for off label uses outside of the FDA-approved indications because for conditions or patient population not listed on the label the drug has not been proven safe and effective.
However, through a major legal loophole, doctors have the authority to decide whether the risk of prescribing a drug for an unapproved use is justified by the benefits. Which means all companies have to do is convince doctors, by whatever means, to prescribe a drug for unapproved uses and deny the drug maker's involvement in their decisions.
Unfortunately, it is the unwitting patients who will endure the stigma of a life-long label as a result of the atypical drugging for profit scheme. When people think about schizophrenia or bipolar disorder they picture patients who hear voices, are delusional, and possibly dangerous to themselves or others. The people misdiagnosed to boost the sale of these drugs, including scores of innocent children, will face a lifetime of suspicion and discrimination by society as a whole.
The Pennsylvania lawsuit says the drug maker influenced doctors to prescribe Seroquel off-label to children for behavior disorders like attention-deficit. The atypicals are not approved to treat children for any condition but a review of records from HMOs and Medicaid programs by researchers at Vanderbilt University found a dramatic increase in the use of the drugs with children, particularly for behavioral disorders, according to the March/April 2006, Journal of Ambulatory Pediatrics.
The study found that between 1995 and 2002, there were 5,762,193 outpatient medical visits by children, aged 2 to 18 years old, at which an antipsychotic was prescribed. The drug companies have doctors in every field of medicine prescribing atypicals to kids, with 32% of the almost 6 million prescriptions, written by pediatricians, family physicians, emergency department doctors, or other types of providers.
The study authors specifically said that there had been no increase in mental disorders that could justify the prescribing increases "as recent studies do not suggest significant increases in the incidence of schizophrenia."
According the study report, these medications have not been studied at all for behavioral disorders and yet, the most common diagnosis was attention deficit disorder or conduct disorder, accounting for 29.0% of all prescriptions.
Critics says, the logical question to ask is how would a pediatrician or family physician, whose practice does not ordinarily include diagnosing or treating mental disorders, ever come up with the idea to prescribe Seroquel to a child for any reason without the input from the drug maker.
As for the benefits of treating kids who are schizophrenic, an August 2006, study by the New York Psychiatric Institute found that the older drugs work far better. The average response rate in children among 8 studies employing the new antipsychotics was only 55.7%, compared to a 72.3% with children in 13 studies who received the older drugs.
The Pennsylvania lawsuit alleges the drug maker influenced doctors to prescribe Seroquel off-label for dementia in elderly patients. On April 11, 2005, after a study revealed that elderly patients with dementia who were taking atypicals were far more likely to die prematurely, the FDA announced the addition of black box warnings about the increased risk of death on the labels of atypicals.
A June 13, 2005, study in the Archives of Internal Medicine, reviewed atypical use by approximately 2.5 million Medicaid patients in nursing homes and found that over half received medications that exceeded the highest recommended dose, received duplicate therapy, or had inappropriate indications for the drugs to begin with. All total, the study determined that more than 200,000 nursing home residents received atypicals but had "no appropriate indications for use."
On October 12, 2006, a study in the New England Journal of Medicine reported that the atypical drugs most commonly used to treat people with Alzheimer's were no more effective than placebos for most patients, and caused serious side effects including confusion, sleepiness and Parkinson's disease like symptoms.
The FDA has acted as an accomplice in allowing atypical makers to suppress other adverse events found in their own clinical trials. According to Dr David Healy, a world-renowned expert on psychiatric drugs, a great deal of data is available on the rates of suicides and suicidal acts in clinical trials on atypicals. He says Zyprexa probably has the highest suicide rate in clinical trial history and calls the absence of available data on suicidal acts and Zyprexa "striking."
By using the Freedom of Information Act to obtain data from the FDA, award-winning journalist, Robert Whitaker, author of, Mad in America, reported that one in every 145 patients who participated in the clinical trials with the atypicals died.
On March 1, 2007, four days after the Pennsylvania lawsuit was filed, Astra became the target of another investigation, when US House of Representative, Henry Waxman (D-Cal), chairman of the House Oversight and Government Reform Committee, sent a letter to Astra, requesting information related to the exact same charges alleged in lawsuit.
The lawmaker's letter asks for a list of all Seroquel trials, studies, or reports; all presentations given to employees who promoted Seroquel; information shown to physicians; presentations related to physician prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.
Critics say the culpability of the doctors in over-prescribing drugs that cause such serious diseases and adverse events cannot be ignored. This critic says, labeling people mentally ill for profit, especially innocent children and the elderly, is an indefensible crime and that all the monsters that engaged in this 10-year off-label marketing scheme should be arrested and sent to prison, and the jailer on duty should throw away the key.
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Michael Haynie
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