On Relaxing Off-Label Meds: Do the Opposite. Especially for Children. Especially Antipsychotics

Steven Francesco
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The US Food and Drug Administration has announced that there will soon be a public meeting  to explore providing drug companies with greater flexibility in promoting off-label indications to doctors.  When it comes to prescribing medications to children, and particularly psychiatric medications, this is a bad idea.

I write both as a former consultant to the pharmaceutical industry, and as a father who lost a son to the toxic effects of antipsychotics prescribed off-label.

Prescribing off-label currently means that the doctors can prescribe drugs to patients for treatment even though there is no formal FDA approval based on efficacy and safety studies for the therapy areas involved. Rather, it is expected that the doctor closely monitor the patient to review safety and efficacy over time.  To be clear, the FDA does not have the legal authority to regulate the practice of the medicine.  However, they do have the right  to regulate the marketing and promotion of a drug.  It is now illegal for drug companies to promote off-label indications to doctors.

The are two drivers for this FDA initiative: the desires of the drug companies to be able to say more to the doctor—albeit based on softer data—in order to expand the use of the products; and two recent court decisions (US v Coronia, Amarin v. FDA) where the judges considered hampering the ability of the sales reps to speak freely to the doctors to be a violation of their first amendments rights to free speech.

This FDA meeting is a good idea.  Off-label prescribing definitely needs to be better thought out.

One flaw in the current system needs to be addressed urgently: All therapeutic areas are not the same.  Off-label may work well in cancer, but can do real harm to children, especially in the area of children’s mental health.  As a nationally known healthcare consultant with over thirty years’ experience in this industry, I thought I knew and trusted our healthcare system; until my only son died from off-label prescribing of excessive amounts of the atypical antipsychotic drug Seroquel.  My son was a bit lethargic on a Friday night, but was in an irreversible coma on Sunday morning, ultimately passing away from a side effect called neuroleptic malignant syndrome.

Children are already the least-protected citizens under the eyes of the FDA.   Every adult has the benefit of FDA-approved labeling that has been created after rigorous clinical tests.  Every doctor has “best practices” guidelines on how to prescribe to adults.  Every pharmacist has software to guide prescribing and point out possible drug interactions in adults.  None of these exist for children’s medications.  This is all due to the lack of data on medication effects in children.  Moreover, while insurance companies carefully monitor doctors’ prescribing to insure efficacy and cost-effectiveness in  medications for adults, there is virtually no analysis of effective prescribing to children.  Relaxing off-label prescribing in children’s medications will increase the risk to children dramatically.

I have just completed a book—actually a dramatic case study covering eight years of off-label prescribing in children’s mental health—based upon my role as a father, a healthcare consultant, and extensive reading and writing as well as a malpractice lawsuit following my son’s death.  I am now an expert with a 360-degree understanding of the weaknesses of off-label prescribing to children for mental health reasons.  I have serious criticisms and recommendations for the physicians, drug and insurance companies, schools and parents.

In the United States today over $20 billion of psychotropic drugs are prescribed to five- to eighteen-year-olds in the mental health category. It is estimated that more than 95% of these drugs are prescribed off-label.  Currently, over 12 million children are taking psychotropic drugs in the US annually.  One CDC study found that in a given month 6% of adolescents in the U.S. reported taking psychotropics.

The drug companies have been fined over $12 billion in the last nine years for the illegal promotion of these drugs to children.  Just last month another case was filed involving the illegal promotion of  Abilify for children.  That means that the playing  field is already—de facto—very extensive. Fines mean little and the FDA rules are clearly not an inhibition to the expansion of off- label business. We should all look at the children’s mental health area as a real-life example of what to avoid in off-label prescribing.

Rather than relax off-label prescribing, we should first tighten up the rules for medications prescribed to children.  We need more data, guidelines and probably regulations.  Our children need more protection, not less.  Second, all indications are not the same.  The children’s mental health sector has been turned into a vast medication minefield for the children and their parents.  The typical medications for children diagnosed with ADHD, bipolar, depression and anxiety have been challenged on their scientific validity.  Many are only too late, given the black-box warnings due to their risk to children. Atypical antipsychotics should be the next black-boxed drug.

Greater flexibility for drug companies’ promotional opportunities is the opposite of what we want and need for our children.  Let’s use this FDA meeting to move regulation of off-label promotion into the 21st century, and thereby reduce the risk in children’s prescribed medications.

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15 COMMENTS

  1. The pharmaceutical industry has weathered some of the most heavy civil penalties in history over their illegal practices, that is, chiefly, off-label drugging. The drug companies are asking for greater liberty with which to pursue their illegal practices. Many people’s lives have been destroyed, and many people have died, owing to those illegal practices. In the case of off-label drugging, this illegal practice is mainly a crime directed against children and young people. You say that rather than relaxing the rules with regard to these illegal practices, we should tighten them. Amen to that, brother.

  2. I am so sorry for your loss. However, I have been hoping that someone from the medical pharm psych complex would eventually speak out. This usually happens when terrible painful things have happened to you or family members I am so sorry you happened to be the one. Thank you for sharing your story. I think the numbers are large, but we, except for this site and others are the silent victims and there are so many that have died.
    It has been incredibly frustrating and ever so hard to be a parent and then for me a person in this corrupt system.
    I wish you luck in your endeavor. Please keep us posted and let us know how we can help. I know more books are coming and maybe the tides are turning.

  3. I am so sorry for the loss of your son to Seroquel. Seroquel is one of the most toxic and potentially fatal and sadly in your son’s case fatal drugs ever created by the big pharma conspiracy. I am a grown woman with too many years of psychiatric drug experience was prescribed Seroquel earlier this year. Like other antipschotics; it caused me the very ant-psychotic thoughts it was supposed to stop. Additionally, it made me into only what could be called a “zombie.” I stopped taking it and asked for another drug. I was yet so enlightened as I am now. My unethical psychiatrist told me to start taking it again at a higher dose; because it takes at least a month to work and I had not given it enough time to work. Right? So, I tried it again and become a worse zombie. I then stopped it for good and later found out on this site how evil it for both mind and body and tragically in the case of your son; fatal.
    As for off-labeling, my mother was prescribed neurontin in addition to two other drugs for an arthritis related back pain. Many times, I do vehemently disagree with my mother; but this time she had enough sense not to take it. There are many other older individuals in her neighborhood who had also been prescribed this drug in addition to others for arthritis related pains. Off-labeling is occurring in prescribing for all ages of patients. It is most dangerous for our most vulnerable; our children and our elderly. Yet, we forget that just because we are between the ages of 18 or 23 and maybe 65, 70, or 75, we forget how vulnerable we are. It is beyond unethical for the children and elderly; but, it affects us all in very dangerous ways. Thank you for your article.

    • Benzos for backpain is another example. Of course without any advice on the side effects or how long maximally one can take it. As a psychiatric survivour I of course knew better, refused and asked for physiotherapy instead but many people won’t question it but will simply fill in a prescription and end up with much worse problems that even the most debilitating pain.

  4. Dear Steven,

    I am very sorry for your loss, and thank you for talking out.

    I was prescribed Seroquel at 25mg in 2005 to replace 25mg of mellaril. Mellaril (thioradazine) was discontinued in the UK because of its heart rythm toxicity. In 2005 Mellaril might have cost 2p per 25mg tablet and Seroquel £1 per 25mg tablet.

    I noticed Seroquel knocked me out very fast so I cut it to about one quarter of 25mg per night.
    I remarked on waking that my ribcage and chest area was a bright pink and the rest of me white. Also – I began to get funny heart beats. Not palpitations but straining in heart beats.

    So I packed up the Seroquel, and my ‘nerves’ were better but my sleeping was reduced, my heart rythm came back to normal, and my body color was okay when I woke up.

    I believe Seroquel has a black box warning, and is banned in the US Military because it was killing young fit soldiers (not overweight middle aged men, with high cholesterol and blood pressure).

    • Seroquel and Zyprexa are both horrific poisons. Both also gave me horrible Restless Leg Syndrome (it really exists – a great example of a iatrogenic illness), which was supposed to stop after I withdrew from them. It didn’t – it took me over a year and iron and magnesium supplements to get rid of it and still not completely – it sometimes comes back.

      Psychiatry is organized crime.

      • Don’t tell me about it!

        I had the involuntary leg movement for years – I couldn’t do anything with it. When I came off the offending medication I rebounded and was given a chronic diagnosis.

        They tried me on something else and it drove me mental so they wrote me up as “pre psychotic”. I then slowly came off strong medications and made full recovery as a result.

    • It’s possible but not in this socioeconomic system. Look at Wall Street – the banks also pay a relatively small fine and go to business as usual and their executives get bonuses instead of a bunk in high security prison. It’s an equivalent of a robber who when caught does not go to prison but only has to give back a small percentage of what he stole and goes free.

  5. Your book is a desperately needed message about the dangers of over-medicating children and off label prescribing. My deepest condolences to you and your family for the loss of your son to Seroquel….from your pain, you have given us a critical message and I will do my best to share your work far and wide…thank you

  6. “The US Food and Drug Administration has announced that there will soon be a public meeting to explore providing drug companies with greater flexibility in promoting off-label indications to doctors. When it comes to prescribing medications to children, and particularly psychiatric medications, this is a bad idea.”
    This is a BAD IDEA period. It’s truly amazing how corrupt they are and I say corrupt because one has to be blind, deaf and stupid and willfully so not to see a huge issue with overprescription of pretty much everything. How does anyone seriously come up with a proposal to expand off-label prescribing? These people are evil because I can’t believe they are so dumb.

  7. So sorry for the tragic loss of your precious son, Steven. I couldn’t agree more with your strong caution against relaxing the standards regarding “off label” use of psych meds with kids. I know from my many years as a school psychologist that the use of psych meds with kids has risen exponentially, with no sign of abatement. And the concept of “informed consent” is regularly violated in that the proposed benefits of medication are overinflated and the risks greatly understated; furthermore, dangerous falsehoods about the drugs balancing brain chemical imbalances and being “like insulin to a diabetic” continue to be blithely perpetuated. Even Dr. Duckworth, the Medical Director of NAMI (which tends to be VERY friendly toward psychotropic drugs and the biopsychiatry mindset), has stated that he NEVER prescribed antipsychotic medications to children. Thank you for this article and for sharing your very valuable “insider’s view” in exposing the dangers our children are being subjected to by the existing psychiatric system.

  8. My condolences for your tragic loss as well.

    Very long story short: About 20 years ago, when I was in my early 30s, I sought help from a psychiatrist for anxiety, insomnia, and depression, (which I now believe was really untreated PTSD due to repeated childhood emotional abuse). I regularly visited this “physician” willingly over the next two decades, as if I were “spellbound” by his drugs.

    During the above-mentioned two decades, this prolific pill-pusher constantly foisted various combinations of Prozac, Paxil, Zoloft, Klonopin, Ativan, Ambien, Seroquel, etc., on me.

    After about 18 years of having taken the above “medications”, and while currently on a Paxil & Klonopin combo, I finally realized that these chemicals were doing much more harm than good for me, so I decided to stop.

    Despite my psychiatrist by then having almost 40 years of experience in his practice which included adults, adolescents, and children, he was ignorant of cautious tapering, dangerous discontinuation/withdrawal effects, etc. Thanks to my many days of internet research, I began my taper much slower than the hasty schedule he had told me, apparently just a guess off the top of his head.

    Unfortunately, during the middle of my taper, a series of extremely stressful real-life events befell me, which were not of my own doing and were totally beyond my control. For some inexplicable reason, I accepted my psychiatrist’s prescription to begin a daily cocktail of 40 mg Prozac, plus 1 mg of Klonopin, plus 50 mg of Seroquel (for a sleep aid).

    I took the above 3-drug cocktail for nearly 2 years–and the apparently permanent consequences on my mental and physical health, my exceedingly horrendous, monumental career and life-ruining decision making, etc., have left me devastated.

    I’m sure the first 18 years of SSRI/benzo combinations left me with many cumulative, severe adverse effects. However, I feel strongest that the 2 additional years of the Prozac, Klonopin, and particularly Seroquel combo were the most destructive of all.