I am a scientist and used to run experiments with drugs on volunteers. I had to go through application after application and the approval process for a single short experiment can take over a year. Why am I bringing this up? According to the Agency for Healthcare Research and Quality 1 out of 5 prescriptions today are written by the clinician for off-label use. Off-label use is using a drug for a condition without FDA approval. This makes it equivalent to research on humans with drugs without their consent.
The FDA says it is legal. Can it be legal? Should it be legal?
Clinical doctors do not practice scientific research; they treat sick people with medications created for the illnesses they have. So how is that possible that clinical doctors can prescribe a drug that was created for illness X to see if it will treat illness Y without the approval of the FDA; without rigorous research that drug created for illness X will also benefit illness Y; and without the patient’s written or even verbal consent!?
I am not quite sure how the medical industry is getting away with this activity of using sick people as guinea pigs without their consent. I find it not only irresponsible and dangerous but downright clueless. Clinical doctors are not trained to do research thus when they prescribed Sumatriptan to adolescents off-label for migraine, after a year of doing so, the FDA came out with not permitting it for the following reasons
“• We did not agree trial SUMA3005 (acute adolescent efficacy study) demonstrated efficacy.
• We provided draft labeling recommendations that needed to be agreed to prior to approval of the supplement.
• We expressed concern that an insufficient number of subjects were exposed for 1 year in trial SUMA3006 (long term trial).
• We requested additional information on the nasal mucosa examinations performed in trial SUMA3006.
• We requested the sponsor provide a safety update for the NDA.” (page 5 of linked document)
Now this is a document from 2003 and since then this drug may or may not be approved for adolescents but that is not the point.
The critical point is that the drug was experimented with on adolescents for 1 whole year as off-label drug and then found to not meet the requirements. This is a huge oops when it comes to medicines in general, since if 1 out of every 5 prescription is for off-label use, than 20% of all drugs in the US are experimented on people without their consent, and without FDA approval.
I really would like to know why this is legal. I actually want to take it a step further and make it illegal! We the people are not guinea pigs or lab rats. We chose to have medications that are proven to treat our specific illnesses if such medications exist. I do not want to have one more doctor in my life tell me “oh but it seems to work for this other condition.” I have heard that before many times. No more.
I recommend you also tell your doctor NO for off-label prescription. It is better to have no medication than something that may make you sick in some other way on top of your already existing illness! If the doctor is not saying whether a drug is prescribed to you off-label or not, do yourself a favor and ask!
Amended after crucial finds. Did you know that you can report if you have an unlisted adverse side effect from a drug? It need not be off-label but any drug, both prescribed and over the counter. The link to consumer reporting is here. Such reporting has lead to a near exponential growth of additional side effects that were originally not listed on drugs at the time of FDA approval. You can see the growth through 2013 via this link and see how much your reporting matters!
Comments are welcomed!
Angela
Clueless Doctors & Scientists 
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Hi Angela,
Where do I begin? Nice post, addressing a complex topic.
Just a few corrections: Clinical doctors are scientifically trained. For example, as I said my undergraduate degree was in Chemistry from Cornell. To graduate from Yale Med School, I completed a thesis where I worked with antibodies for a skin cancer called mycosis fungoides (specific lymphoma of the skin).
One’s entire training is spent thinking scientifically. Many well-trained clinical doctors perform scientific research, but all competent doctors understand and can dissect scientific research.for clinical applications.
As for off-label use of prescription medications, I understand your points and agree with your concerns. There are many incompetent physicians, who practice at some of the most-prestigious institutions, whose off-label use are motivated by MONEY, not healthcare. .
For example, Dr Alice Newton practices at MGH and Boston Childrens Hospital. Her diagnoses are based on the highest bidder. Look at Tufts Medical Center, they attribute my syncope to intoxication but did not do an alcohol level. They were WRONG!
The problem I see is in many Liberal States such as Massachusetts justice is just another meaningless word, and Health care is rare. By contrast, medical errors, missed and misdiagnoses are common especially when they are for sale without downside.
The field of medicine is dirty business….I am glad to have left the field.
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I totally agree Angela. I also know they are scientifically trained but those of us trained specifically for medical research have to go through ethics committee approval and various permits plus a rigorous patient/volunteer consent form before we can do any experiments. A clinical physician–no matter how well trained–is neither receiving ethical approval nor patient consent for the experimenting–and we also lose the information since they are not required to report on the outcome.
Thus not only is off-label prescription wrong based on who is doing it but also the purpose in that it neither adds not subtracts from our current knowledge. All it does is paying for the medication to the pharmaceuticals but no one gets smarter and we may risk the health of the patient.
The FDA has a record keeping system on unreported (by pre-approval medicine tests–the various adverse side effects. You can see at this link that in 2013 there were 1.2 million additional adverse side effects reported–these are side effects not listed on the drugs when they are permitted: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm. The growth in adverse side effects over the years is a near exponential growth and most side effects are never reported only the drugs are stopped. I stopped several drugs myself before I found the reporting form, which I now use: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1 where a patient can place in reports of problems with drugs. This has been the best kept secret. I will actually amend the article with these links!
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You know Angela the process of drug approval makes even indicated use off-label.
The researcher appears to be under IRB oversight, and that is a problem. Most of their findings can be bought at the right price. Remember, there is very little oversight when money is being made.
Geez I have nothing good to say about any industry or system in this country. However, I am thankful I still have the freedom to say Fuck the Police.
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wow Angela, I had no idea about that. It is definitely starting to sounds like a nasty crocked industry…can you explain why the process of drug approval makes even indicated use off-label? I am not sure I understand that. I noticed that all drugs now come with the note that “your doctor may prescribe this medicine for uses other than listed” making off-label sound legit. And according to FDA it is legit.. but then I see a lot of legal action as well…
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Angela it only takes two positive clinical trials for FDA approval….that could be 2 out of 100 or 10000…it does not matter.
The numerous other failed trials, most showing harm and / or lack of effectiveness are not reported..
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Oh my! That is terrible!!!! I can hardly wait to get to attack this system full time! Thanks Angela! ❤
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