Federal regulators have pulled a lot of bizarre stunts over the years, but this one is a real head-scratcher. Just over a month ago, the manufacturer of an antidepressant drug called Lexapro (Forest Laboratories Inc.) was brought up on charges for illegally bribing pediatricians to prescribe it for children, for which it was not approved. So what does the FDA do? They announced last week that they had given the green light for Lexapro to be used on patients from 12-17 years of age. To make things even weirder, this ruling contradicts Forest Labs' own statement that Lexapro had not proven itself in studies to effectively maintain control of depression symptoms in adolescents.The timing of this move makes absolutely no sense, and it screams of corruption and conflict of interest, something the FDA is no stranger to. The really odd thing about this all is that the FDA's ruling actually overrides Forest Labs' findings that Lexapro is ineffective for treating depressed children, and that it is highly dangerous for them as well -- even more so than for adults. If you visit Forest Labs' Lexapro website where their branding mantra is "POWER TO ENJOY LIFE", they have clearly posted an ominous warning right under their Big Announcement:
LEXAPRO is now approved for
acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents aged 12-17.
acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents aged 12-17.
"Antidepressants increased the risk, compared to placebo, of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders."
For the FDA to make the decision to legalize the prescriptions of Lexapro to children under any circumstances is highly questionable, but when it was done in the shadow of the indictment of Forest Labs, it becomes scandalous.
What Kind of Corruption is Going on Here?
The accusations against Forest Labs that were announced last month were the culmination of a five-year investigation by the Federal Department of Justice. Prosecutors found that executives in the company had told their sales and marketing people to push pediatricians to prescribe Lexapro and its chemically similar sister drug Celexa to children and adolescents, even though it had not received FDA clearance to do so. However, this is a common occurrence in the world of Big Pharma, and the practice is called "off-label" prescription and is not technically illegal. However, it is illegal for drug companies to urge physicians to do so.
Yes, it sounds unbelievable, but if a physician wants to use a drug for something other than what it is designed to do because he feels it may "help" his patient, he is legally free to do that in some cases. Where Forest Labs got themselves in trouble, is that they were caught pushing off-label use through illegal "marketing" methods such as offering bribes to doctors in the form of cash, tickets to sporting events and Broadway shows, fishing trips, spa visits, and other expensive perks. Employees of Forest Labs were also instructed to ignore studies that showed less than favorable results of these drugs on kids, and to highlight studies that gave the results the company was looking for. This cat and mouse game is also a very common practice in the FDA/Big Pharma network. Lexapro is Forest's biggest product ($2 billion in annual sales and number 15 on the list of all US drug sales), but apparently they weren't satisfied with that.
Just How Dangerous is Lexapro Anyway?
Many doctors, and thus their patients, have been told by drug company reps that Lexapro is "non-habit forming." However, the truth of the matter is that this toxic drug has over 250 known side-effects, either during use or when stopping use of the drug (withdrawal symptoms). Some of the major side effects include:
What Kind of Corruption is Going on Here?
The accusations against Forest Labs that were announced last month were the culmination of a five-year investigation by the Federal Department of Justice. Prosecutors found that executives in the company had told their sales and marketing people to push pediatricians to prescribe Lexapro and its chemically similar sister drug Celexa to children and adolescents, even though it had not received FDA clearance to do so. However, this is a common occurrence in the world of Big Pharma, and the practice is called "off-label" prescription and is not technically illegal. However, it is illegal for drug companies to urge physicians to do so.
Yes, it sounds unbelievable, but if a physician wants to use a drug for something other than what it is designed to do because he feels it may "help" his patient, he is legally free to do that in some cases. Where Forest Labs got themselves in trouble, is that they were caught pushing off-label use through illegal "marketing" methods such as offering bribes to doctors in the form of cash, tickets to sporting events and Broadway shows, fishing trips, spa visits, and other expensive perks. Employees of Forest Labs were also instructed to ignore studies that showed less than favorable results of these drugs on kids, and to highlight studies that gave the results the company was looking for. This cat and mouse game is also a very common practice in the FDA/Big Pharma network. Lexapro is Forest's biggest product ($2 billion in annual sales and number 15 on the list of all US drug sales), but apparently they weren't satisfied with that.
Just How Dangerous is Lexapro Anyway?
Many doctors, and thus their patients, have been told by drug company reps that Lexapro is "non-habit forming." However, the truth of the matter is that this toxic drug has over 250 known side-effects, either during use or when stopping use of the drug (withdrawal symptoms). Some of the major side effects include:
- Gastrointestinal: (cramps, diarrhea, constipation difficulty swallowing, vomiting)
- Cardiovascular: (irregular heartbeat, chest pain abnormal EKG, varicose veins)
- Muscle pain
- Aches and pains
- Joint pain
- Loss of balance
Tremors - Involuntary muscle contractions
- Psychiatric: (crying fits, auditory hallucinations, abnormal dreaming, depression -- the very thing it is supposed to treat!)
- Asthma and other allergies
- Acne and other skin disorders
- Shortness of breath
Experts also urge caution when withdrawing from Lexapro. Potential problems include many of those listed above, plus:
- Cardiac arrest
- Gastric ulcers
- Irritable Bowel Syndrome
- Increased psychiatric symptoms
- Kidney disease
- Vision problems: (macular degeneration, detached retina)
Google "Lexapro withdrawals" or "weaning off of Lexapro" and you will find literally hundreds of sites and forums of individuals trying to wean off of Lexapro. Drugs.com contains a discussion forum with 314 pages of posts devoted only to people trying who are trying to stop Lexapro. Evidently some have been trying to get off this "non-addictive anti-depressant" from 3 to 8 months, and yet are still having tremendous difficulties in accomplishing their goal.
Unfortunately, as you can see, you can't always trust what your doctor tells you and the FDA continues to show us over and over just how much they really do NOT care about our health and well-being. Be sober and wise about any drug that is prescribed for you or your loved ones. Research and do your "due diligence." For me, I will choose NOT to get my POWER TO ENJOY LIFE from a pharmaceutical drug.
We know that big pharmaceutical is in bed with the FDA, there not there for our best interest, it is greed and pay under the table.
ReplyDeleteThis is indeed an outrage. Thanks for pointing it out. I'm passing this on to all my friends, and advise anyone else who sees it to do the same. We have to be diligent after our own health these days; we can't depend on the government to do it for us, obviously!
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