Although peddling psychiatric drugs for off-label treatment of every ailment known to man is highly profitable, it is also illegal. Marketing schemes that increase the rates at which drugs are prescribed for off-label use result in the sale of drugs that have not been proven safer or superior to FDA approved medications already on the market.
That said, it’s time to quit blaming the pharmaceutical industry exclusively for off-labeling marketing. The fact remains that drug makers could not sell their new and relatively untested drugs if not for the doctors who take on the role of middleman pusher.
Since the arrival of selective serotonin reuptake inhibitors antidepressants (SSRIs) and atypical antipsychotics on the market, countless studies have shown the so-called "new generation" of psychiatric drugs to be ineffective and dangerous. But for years, drug companies have successfully manipulated data, suppressed negative studies, and reported only the clinical trials with positive results.
However, by now plenty of warnings have been issued about these drugs, and doctors who continue to prescribe them due to financial incentives from pharma, or because they happen to be approved by the compromised FDA, should not be let off the hook. If it takes a few highly publicized lawsuits against prescribing physicians to knock some sense into these doctors, so be it.
Medical professionals need to start conducting their own research, which means doing more than relying on medical journal abstracts on the internet that, for the most part, are formatted to report misleading claims without mentioning the contradictory data.
On January 13, 2005 WebMD Medical News reported a government study that showed more Americans than ever are being treated for substance abuse, depression, and other mental health disorders, but the treatment they are getting is increasingly limited to prescription drugs alone.
The study assessed changing patterns in the treatment of mental illnesses from the mid-1990s to 2001, and determined that mental health drug costs rose 20% each year.
According to economist Samuel H Zuvekas, PhD, who conducted the analysis, about 80% of the growth in expenditures can be explained by the increase in the use of SSRIs and other antidepressants, and high-priced schizophrenia drugs called "atypical antipsychotics."
Worldwide sales of anti-psychotics went from $263 million in 1986 to $8.6 billion in 2004, and antidepressant sales went from $240 million in 1986 to $11.2 billion in 2004. For these two classes of drugs combined, sales went from $500 million in 1986 to nearly $20 billion in 2004, a 40-fold increase, according to Robert Whitaker, best-selling author of Mad in America.
For over 15 years, millions of Americans have been prescribed SSRIs for off-label treatment of a multitude of newly invented disorders. Mr. Whitaker says, "what we're seeing is nothing more than the creation of a larger market for drugs."
"If you think about it," he explained during an August 2005 interview with Street Spirit, "as long as we draw as big a circle as possible, and expand the boundaries of mental illness, psychiatry can have more clients and sell more drugs."
"So there's a built-in economic incentive to define mental illness in as broad terms as possible," he continued, "and to find ordinary, distressing emotions or behaviors that some people may not like and label them as mental illness."
Prozac is the only SSRI approved by the FDA for treating depression in children. It is reportedly the only SSRI shown to be effective in two pediatric trials, the number required to obtain FDA approval. But to put the term "effective" into perspective, all a drug has to do to pass two trials is show it had better results in children treated with the SSRI than children taking a placebo. The trick is that a company can do 100 trials to get the necessary result if need be. It stands to reason that sooner or later the SSRI is bound to do better than a placebo when the odds are 50-50.
However, over the past couple of years this practice has been coming under scrutiny. New York State Attorney General Eliot Spitzer nailed GlaxoSmithKline for fraud in 2004 for hiding studies that, "not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo."
The suit said the company had conducted at least five studies on the use of Paxil on children, but only published and disseminated the results of one.
Spitzer drew attention to the fraud charges by publishing a 1998 e-mail in which Glaxo officials discussed the studies and the need to "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact."
Although Paxil was never approved to treat depression in children, according to Spitzer, in 2002 doctors prescribed the drug off-label to children two million times, the same year that Paxil was Glaxo's top seller, with sales of $3.8 billion. To settle the charges, Glaxo agreed to pay $2.5 million to the State of New York.
An April 10, 2004 article in the British Medical Journal, citing Jurendi et al, criticized the authors of published studies on SSRIs for exaggerating benefits and downplaying their harm. As an example, Jurendi noted that a trial of 93 kids on Paxil produced 11 serious adverse events compared with only two in the placebo group. Despite this, and the fact that seven of the Paxil patients were admitted to the hospital, the authors of the study claimed Paxil "was generally well tolerated in this adolescent population, and most adverse effects were not serious."
As for the effectiveness of SSRIs, in May 2005 the Washington Post reported: "Despite a dramatic increase in treatment of psychiatric disorders during the past decade, there has been no decrease in the rate of suicidal thoughts and behavior among adults, according to a federal study primarily funded by the National Institute of Mental Health."
Although studies have shown atypical antipsychotics to be associated with a growing number of serious adverse effects, doctors continue to be prescribe them off-label to treat a host of health problems, for senior citizens, persons in state institutions, and children.
In 2004, atypicals became the fourth highest grossing drugs in the US, with $3.4 billion of their total sales funded by state Medicaid programs, according to the article “Medicating Aliah” in the May 2005 issue of Mother Jones Magazine.
Recent research has shown that nursing home residents are being fed antipsychotics in record numbers. A June 13, 2005, study published in the Archives of Internal Medicine examined the quality of antipsychotic prescriptions in approximately 2.5 million Medicaid beneficiaries in nursing homes and found that “over half (58.2%),” received antipsychotic drugs that exceeded the maximum recommended dosage, received duplicate therapy, or under the guidelines, had inappropriate indications for the medications to begin with.
The study found that more than 200,000 nursing home residents received antipsychotic therapy but had “no appropriate indications for use.” Pharma will stop at nothing when it comes to making money off children. On April 25, 2005, the Ohio Columbus Dispatch reported an investigation of state Medicaid records that found 18 newborn to three-year-old babies in Ohio had been prescribed antipsychotic drugs in July 2004.
During an investigation of children under state care in Pennsylvania, Dr. Stefan Kruszewski, a Harvard trained psychiatrist, found “cases where children were placed in state-funded residential treatment facilities, sometimes for years, and were heavily drugged with the new antipsychotics and anticonvulsants.”
Reports of the adverse effects of the drugs on children are beginning to emerge. The Children's Hospital of Philadelphia recently found that 19% of newly diagnosed Type 2 diabetic children were being treated with psychiatric drugs like Zyprexa, Risperdal, Geodon, Seroquel, Clozaril, and Abilify, according to “Robert F. Kennedy Jr. vs. the Medical Elite,” by Mark Sircus Ac, OMD in June 22, 2005.
"Many of these drugs carry black box warning to alert MD’s about the dangers of diabetes," Mr. Sircus pointed out. "The most studied adverse effect of the newer generation of antipsychotics is their association with hyperglycemia, in some cases leading to ketoacidosis, coma, or death."
According to Dr. Kruszewski, the new atypicals substantially increase the risk of obesity, diabetes type II, hypertension, heart attacks, cardiovascular complications, and stroke.
“The drug makers had this information and simply ignored the problem," he says.
Dr. Kruszewski is apparently correct judging by hidden studies that have come to light. After years of prescribing Risperdal for off-label use by millions of patients in all age groups, on July 24, 2004, the Miami Herald reported the “maker of a billion-dollar antipsychotic medication has acknowledged misleading doctors and other healthcare providers about the safety of its product, minimizing potentially deadly side effects.”
As it turns out, the maker of Risperdal had two billion good reasons to hide the dangers associated with the drug because Janssen earns about $2.1 billion in annual sales from Risperdal, according to the Herald.
During his interview with Street Spirit, Mr. Whitaker summed up the devastating effects on society as a result of the marketing practices promoting the sale of the new psych drugs:
“Unfortunately, the cost is dishonesty in our scientific literature, the corruption of the FDA, and the absolute harm done to children in this country drawn into this system, and an increase of 150,000 newly disabled people every year in the United States for the last 17 years,” he said. “That's an incredible record of harm done.”
But worst of all, Mr. Whitaker says: “No one says that the mental health of the American people is getting better.”
Evelyn J. Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption in government. She can be reached at: firstname.lastname@example.org.
* Injured parties seeking justice can find more information at: Lawyers and Settlements
Other Articles by Evelyn J. Pringle
Online: Black Market Profits In Plain Sight