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No Approved Therapeutic Claims

Food supplements carry the “no approved therapeutic claims” label. Filipino patients who do not fully understand what the label means may stop their medication when taking these supplements and come to harm. There are more ads for supplements than doctors speaking up on potential harm. This is my summary that connects three links shared on my Facebook network recently –

  1. Drop ‘no therapeutic claim’ from labels – DOH by Jocelyn R. Uy on
  2. What do doctors say to ‘alternative therapists’ when a patient dies? Nothing. We never talk by Ranjana Srivastava on The Guardian
  3. The dangerous silence of academic researchers by Y. Claire Wang on The Chronicle of Higher Education


By order of the  Food and Drug Administration (FDA), the “No Approved Therapeutic Claims” is now to be replaced with –

Mahalagang paalala: Ang (name of product) ay hindi gamot at hindi dapat gamiting panggamot sa anumang uri ng sakit (Important reminder: This is not a medicinal drug and should not be used to treat the symptoms of any disease).

The article on ‘alternative therapists’ discusses cancer patients who have died pursuing alternative treatments. I’m not an oncologist but certainly there are many supplements being advertised for diabetes and thyroid disorders too.
I try to maintain openness with my patients so that they feel comfortable asking me about supplements they are taking or planning to take. Here are some of the things they’ve told me that threaten the MD-patient relationship:
  • Don’t tell your doctor about this supplement. She will never agree to you taking them anyway. When I am asked about a supplement, I request my patient to bring the bottle or packaging so I can check for myself what it contains. I discuss with the patient the ‘no approved therapeutic claim’ label. I explain what effects can be expected from vitamins, herbs or supplements as far as science can. I am upset that my patients are told to hide things from me. How can I take good care of a patient when I don’t have the complete picture?
  • This vitamin supplement is different. You are taking Brand X that your doctor approved? What do you notice? Your urine smells different with Brand X. That’s because Brand X gets urinated. Our vitamin supplement Y is different. Your urine will not smell any different. That means it was absorbed by your body completely. The argument sounds logical. I must now spend precious time at this clinic visit to explain. How can I teach my patient to evaluate claims such as these? 
  • Your doctor does not want you to take our product because then you will get better and no longer require her services. You will no longer need to follow up with her if you get better. That is why she tells you not to take this supplement. This by far is the worst I have heard! I try as calmly as I can to tell my patient that to become a doctor is to answer a call to serve. First do no harm is something we strive to follow. Doctors do their work knowing that by doing it well, they move towards the extinction of their profession. Your doctor wants you to get better!

One thing I have found helpful when a patient asks about a supplement is to ask WHY he/she is contemplating on taking it. The ensuing conversation often leads to misconceptions about their disease that I can then explain. Sometimes it leads to my patient admitting that he/she feels he/she is not getting any better with the medication I am prescribing. There are some patients who still cannot believe that there is no cure for diabetes as yet. They are daunted by the prospect of taking “maintenance” medications. They feel that they have to “protect” their kidneys and liver from the medications I prescribe, by taking these supplements. In some instances, the conversation has led to a discussion of prices. It can go both ways. Either the supplement is more expensive than the medication I prescribe, hence more effective; or the supplement is cheaper than what I prescribe, and hence a better option.

Let me end with William Osler who said –

One of the first duties of the physician, is to educate the masses not to take medicine.

I think the quote serves to remind us that doctors need to discuss lifestyle change, preventive measures or wellness as much as we prescribe medication.






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