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.
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.
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