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."
"It is clear," Mr Tenpas said, "from our experience that drug company violations of the law are causing government health-care programs to pay too much for prescription drugs."
Evelyn:
I noticed today that you have an article that pertains to a situation I am facing and I plan to use the article in handling the situation. I would appreciate any thoughts you may have concerning it or if you would rather not express an opinion, I would totally understand. Almost 2 years ago my Dad's urinary function was blocked by an enlarged prostate. My Dad is 85 years old and they didn't want to do surgery but ultimately they did and he is doing pretty well physically though he is still on Flomax for the condition. Because his weight was very low on admission to North Shore Hospital in Manhasset, New York, his doctor and his second wife, Jan,(who is a nurse there in Hospital Administration) had him put on 10 mg of Lexapro a day which as far as I know, he is still on. I am alarmed at the dangers of this drug particularly heart attack. I am planning to show him him the data on the dangerousness of Lexapro and SSRIs because his second wife said he had an irregular heartbeat and heart problems before being put on Lexapro (which to me is asking for disaster). They installed a Pacemaker in his chest but only after he had been put on the Lexapro. I want to show him the adverse data and see if he will agree to go see another Doctor to get a 2nd opinion on whether he should stay on the Lexapro or not because it is extremely dangerous, and look at if he could be safely gradually weaned off of it under supervision of a competent Doctor. My Dad's second wife, Jan, started screaming at me in a threatening manner when I once mentioned my concerns about my Dad taking Lexapro in the past. She told me not to say anything because he could have a heart attack and die (which is exactly what I think might happen to him if he is kept on the Lexapro). I don't feel I am violating any law about offering medical advice or acting as a doctor in showing my father the adverse data and asking him if he will agree to go for a second opinion regarding staying on the Lexapro. My Dad has told me he has given given his 2nd wife, Jan, legal control over his medical care. I feel if I challenge Jan and my Dad's doctor that they are arrogant enough to do almost anything to punish one who challenges their viewpoint. I worry about being arrested for abusing my Father by asking him to go for a 2nd opinion. Do you know of this ever happening? Any thoughts or suggestions in case that should happen? Again, if you would rather not express an opinion on this I would totally understand. Thanks for your emails and information and for these articles.
by
larrybone (0 articles, 0 quicklinks, 0 diaries, 9 comments)
on Friday, February 23, 2007 at 9:04:05 AM
