Off-Label Sales of SSRIs Leads To More Litigation

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By Evelyn Pringle (about the author) Page 1 of 5 page(s)

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For OpEdNews: Evelyn Pringle - Writer

Off-label prescribing of prescription drugs overall is widespread in the US, but nowhere is it more prevalent than with the antidepressant drugs known as selective serotonin reuptake inhibitors. A study in the June 2005, Journal of Clinical Psychiatry, found that 75% of the prescriptions written for SSRIs were for treatments not approved by the FDA.

The study's lead author, Dr Hua Chen, an assistant professor at the University of Houston, said the findings reveal a significant gap in the US drug safety system and off-label prescribing regularly exposes consumers to drugs that are untested for their condition.

The FDA approves drugs for uses that have been tested and proven to be safe and effective. The term off-label means prescribing a drug for a use not approved or for a different patient population, such as children instead of adults, or at a different dose or duration than was determined by the FDA to have a favorable risk-benefit ratio.

While doctors may legally prescribe a drug for an off-label use, drug makers are barred from promoting a drug for unapproved uses, but it is a widely known that it occurs on a regular basis. For instance, SSRIs are still being prescribed off-label for a multitude of unapproved conditions to patient groups that includes children as young as toddlers, the elderly, and pregnant women.

Over the past 20 years, SSRIs have been prescribed off-label for everything from anxiety to pain, insomnia, shyness, menstrual discomfort, dementia, restless leg syndrome, and a host of other invented disorders sold to the public with the help of industry funded front groups and PR firms.

Possibly with the exception of Vioxx, in the end SSRIs will probably hold the title for not only the most side effects but also for the most lawsuits filed against SSRI makers due to their conduct of concealing studies that identified serous adverse events while at the same time overstating their efficacy, in the name of profits.

This class of drugs has now been found to be associated with suicidality, extreme violence and homicide, several life-threatening birth defects, abnormal uterine or gastrointestinal bleeding, a decrease in bone mineral density, fertility problems, sexual dysfunction, and a severe withdrawal syndrome.

In large part because the SSRI makers have been ripping off public health care programs by billing the government for the vast majority of off-label prescriptions, Federal and state law enforcement agencies are zeroing in on the drug companies and the doctors who are writing the off-label prescriptions as a result of kickbacks of some form or another.

The various illegal marketing schemes are taking their toll on public health care programs. According to the US Department of Health and Human Services, in 2005, Medicaid paid $41 billion for prescription drugs, well over 4 times the $8.9 billion spent in 1994.

Several Congressional Committees are currently investigating the off-label promotion of drugs by the pharmaceutical industry. While testifying at a US 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, informed members of Congress about the adverse effects of prescribing drugs for unapproved uses.

"Off-label promotion," he said, "may lead physicians to prescribe a product for a non-approved use based on false, misleading, or erroneous information to the medical detriment of their patients."

"In addition," Mr Morris continued, "off-label promotion fundamentally circumvents the FDA drug approval process, on which Americans rely to evaluate the safety and efficacy of pharmaceutical products."

Mr Morris warned that physicians may be under the wrong impression that they can demand "kickbacks from drug companies with impunity," because in the past prosecutors have focused on the drug makers paying the kickbacks.

But in cracking down on doctors, Mr Morris told the Committee that the OIG plans to use its authority to impose monetary penalties and the exclusion of doctors from public health care programs who are found to be accepting kickbacks.

Ronald Tenpas, associate deputy attorney general in the Department of Justice, testified about the harm caused by the corruption of doctors on the public as a whole. "By inducing physicians to prescribe for uses that have not been approved," he said, "either by promoting compromised "science" or offering financial incentives, manufacturers are subverting a healthcare system that necessarily relies on the objective medical judgment of practitioners, and their actions may also harm the public health."

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