If a drug is FDA approved for one indication, doctors may prescribe it for another. But it is illegal for drug companies to promote a drug for off-label uses in attempt to influence doctors prescribing habits as a means of boosting sales.
Off-label refers to treating conditions not listed on the drug's label or increasing the dose or duration of treatment beyond that specified on the label. It also means prescribing drugs in combinations with others or prescribing a drug to an unapproved patient group such as children or the elderly. If an indication is not listed on the label it means the drug has not been tested and approved as safe and effective for that use.
Government programs cover drugs that are approved by the FDA when they are medically necessary. However, when off-label promotion is used to induce doctors to prescribe drugs for unapproved uses, public health care programs pay for those prescriptions and government spending goes up.
The list of health risks found to be associated with SSRIs over the past decade is staggering, but not as staggering as the number of people who have been prescribed these drugs for bogus disorders including everything from shyness to the latest invented disorder called the "hoarding syndrome."
The SSRIs have now been positively linked to adverse effects that include suicide, extreme violence and aggression leading to homicide, several serious life-threatening birth defects, fertility problems, sexual dysfunction, a dangerous long-lasting withdrawal syndrome and the list goes on and on.
With the new Democrat controlled Congress, the investigation of illegal off-label marketing schemes is picking up speed and investigations will no longer be limited to the drug companies. The middle man pushers, also known as prescribing physicians, on the receiving end of kickbacks will also be placed under intense scrutiny.
Public hearings on the issue have already begun. While testifying at a House Committee on Oversight and Government Reform on February 9, 2007, Lewis Morris, Chief Counsel at the Department of Health and Human Services' Office of Inspector General, said: "Kickbacks potentially increase the costs to Federal programs because they encourage overutilization and may encourage the prescribing of more expensive drugs when clinically appropriate and cheaper options (such as generic drugs) may be equally effective."
"Equally troubling," he said, "kickbacks can compromise the independence of medical decision making by putting the financial interests of the physician ahead of the welfare of the patient."
"In OIG's experience," Mr Morris told the committee, "kickbacks offered to prescribing physicians by pharmaceutical manufacturers take a variety of forms, ranging from free samples for which the physician bills the programs to all-expense-paid trips and sham consulting agreements."
According to testimony at the same hearing by, Ronald Tenpas, associate deputy attorney general in the Department of Justice, one kickback scheme discovered involved providing free drugs to doctors and then instructing them how to bill Medicaid and Medicare for the drugs causing the government to even pay for the illegal kickbacks used to induce doctors to prescribe the drugs.
"The Anti-kickback Statute," Mr Tenpas says, "remains a vital law enforcement tool in assuring that sound medical judgment is not subverted by the payment of inducements that sometimes cause medical professionals to prescribe drugs based on financial considerations and not medical necessity or safety."
Mr Morris noted that in the past, prosecutors have focused on the companies paying the kickbacks and not on the prescribing doctors. "This may have created the misimpression by some physicians," he said, "that they can demand kickbacks from drug companies with impunity."
With this in mind he told the panel, the "OIG has stepped into this breach and is using its authority to impose program exclusion and significant monetary penalties to target these kickback recipients."
"Hopefully," Mr Morris told the committee, "OIG administrative enforcement also will prompt physicians to think twice before accepting kickbacks from pharmaceutical companies."
However, kickbacks are but one method used to influence doctors prescribing habits. During an October 10, 2002, lecture in Rome, Dr Lawrence Diller, a behavioral-developmental pediatrician, and author of, The Last Normal Child, said advertising and promotion to physicians may be the most alarming and pernicious influences.
"For years," Dr Diller said, "doctors in the U.S. have been inundated with professional magazine ads, drug salesman visits, free samples for patients and more recently monetary inducements to attend "educational" seminars or act as consultants for meetings that aren't anything more than promotional events for a new drug."
Drug companies also use direct to consumer advertising to promote off-label uses. According to Dr Diller, "the role of the pharmaceutical industry cannot be underestimated in its influence on the way American's think about themselves and their children."
In 2004, the FDA cited two antidepressant makers for over promoting the use of their drugs in commercials aimed at consumers. It cited Effexor maker, Wyeth Pharmaceuticals for a radio ad in which the announcer said:
Hey, you, listening to the radio ... how're you feeling these days? OK? Not bad? Come on, is that where you want to be? When was the last time you did something you once looked forward to doing? You know, symptoms of depression could be holding you back.
At the time, Effexor XR, was approved to treat major depressive disorder and the FDA said the radio ad failed to convey the "serious nature of major depressive disorder" and to "distinguish symptoms of depression from variations of normal daily functioning."
"As a result," the FDA stated, "it broadened the audience for Effexor XR."
GlaxoSmithKline also received a citation for advertising Paxil on television for too many types of patients. The FDA said the drug was approved to treat social anxiety disorder, characterized by "marked and persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny."
A Paxil TV ad, the FDA advised, in which characters became stressed over social situations such as being at a party, failed to distinguish between social anxiety disorder "and lesser degrees of performance anxiety or shyness that do not generally require psychopharmacological treatment."
The success of SSRI off-label promotion efforts is evident in all age groups. According to Dr Richard Kadison, chief of mental health at the University Health Services, Harvard University, in the September 15, 2005, New England Journal of Medicine, "the number of prescriptions has increased dramatically over the past decade; it is estimated, for example, that 25 to 50 percent of U.S. college students who are seen in counseling and at student health centers are taking antidepressants."
At least in part, he says, such consumer demand reflects our bombardment with advertisements imploring us to "ask your doctor if this pill is right for you."
"This type of marketing is a double-edged sword," Dr Kadison warns, "not only raising awareness of common problems such as depression ... but also implying that there is a magic bullet for complex problems and enticing some healthy people to seek their own magical boost."
Christopher Kilmartin, professor of psychology at the University of Mary Washington, also blames advertising for the increased use of psychotropic drugs. It used to be companies could only market to physicians and psychiatrists, he says, but now they are allowed to create a market by not only advertising a drug to treat a disorder but with ads to convince people they have a disorder.
According to Dr Kilmartin, normal human struggles are pathologized and then people feel as though they are deficient and need some sort of treatment.
But kids are being recruited as SSRI customers long before they head to college. One of the most successful, and alarming, off-label marketing scheme that needs to be investigated is the TeenScreen program. By use of TeenScreen, the drug companies have gained access to the nation's 50 million public school children.
Billed as a mental illness screening program aimed at suicide prevention, it is already being administered to students in schools all across the country and children are being labeled mentally ill on a regular basis, with the only treatment offered naturally being drugs.
Tugging at the heartstrings, TeenScreen is presented to naive parents as a harmless little survey that may save their kids from suicide. However, parents are not being told about the life-long consequences that can result from a child's diagnosis of mental illness by way of this harmless survey.
Critics say this particular scheme is so evil that people can not even bring themselves to consider that drug companies would go so far as to implement this type of program in the public school system to drug kids for profit. They also say that parents had better think again.
There is no teen suicide epidemic in this country. In fact a recent government survey found that although SSRI use has multiplied every year for the last 10 years in a row, there has not been any decline in the suicide rate.
The TeenScreen program is set up to recruit patients from the most lucrative and consistent customer base available in the US and few other off-label marketing schemes have drawn the outrage expressed over this one.
The family of a teen who was labeled mentally ill by TeenScreen in Indiana is suing the school for allowing their daughter to be screened without their knowledge and consent.
The young girl took the survey and was diagnosed with not one, but 2 mental illnesses: obsessive compulsive disorder and social anxiety disorder.
Even government experts say suicide prevention screenings do not work. On June 16, 2006, Ned Calonge, former chairman of the US Preventive Services Task Force, and now the chief medical officer for the Colorado Department of Public Health and Environment, who in 2004 reported that the Task Force found no evidence that screening for suicide reduces suicides or that screening tools are accurate, spoke to the Washington Post and said the same findings still apply:
"The panel would reach the same conclusion today... Whether or not we like to admit it, there are no interventions that have no harms... There is weak evidence that screening can distinguish people who will commit suicide from those who will not... And screening inevitably leads to treating some people who do not need it.
"Such interventions have consequences beyond side effects from drugs or other treatments... Unnecessary care drives up the cost of insurance, causing some people to lose coverage altogether."
Government investigators are going to have to delve much deeper than looking for kickbacks to doctors if they plan to have any success in shutting down the highly profitable off-label marketing pipeline to kids.
All that said, the worst part about drugging children with SSRIs, is that after hundreds of millions of prescriptions have been written, experts now say they do not work with kids. In the vast majority of studies, most of which were kept hidden by the SSRI makers and only surfaced as a result of litigation, the drugs were no more effective than a placebo.
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"An increased risk of suicidal behavior," he told the panel, "is certainly not justified by these minimal benefits."
"Clinically meaningful benefits," Dr Antonuccio testified, "have not been adequately demonstrated in depressed children, therefore, no extra risk is warranted."
"The highest possible standard should be applied to scientific data involving drug treatment of children," he told the panel, "because children are essentially involuntary patients."
He pointed out the unfortunate fact that parents make children take the drugs whether they want to or not.