No Approved Therapeutic Claim/Use!

I had always wanted to talk about this with my patients but I have not had the time to sufficiently discuss this.

As a medical doctor I cannot and will not endorse any product which has a 'No Therapeutic Use' on its label. I am for any thing herbal and natural but it does not mean that I will disregard the safety of my patients.

I have a professor in Medschool that is an advocate of herbal medicine but she is also a medical doctor. And so, while advocating for herbal medicine, she tediously explained the process and the science of preparing an herbal medicine, and so let's take some important points about it:

• Herbal medicine preparations should be an exact ....science. This simply means that exact measurements should be used. Meaning if you prepare (let's take for an example Sambong leaves) leaves, and you are instructed to take 5 leaves. You should take leaves with proportionally same size with each other. There are some preparations that prescribes the exact size of the leaves like for example (I am only hypothesizing here) Sambong leaves should have 1-inches leaves while recommendations for Malunggay leaves is only 1-cm leaves. AND there are different preparations for barks, roots, fruits, etc.
• Even the procedures in preparations should be exact. As my mentor explained, preparing a decoction is also exact meaning a certain decoction is prescribed with a 1 cup water while others are prescribed with a 1 glass water (yes a cup is different from a glass!). If you boil a decoction for 30 minutes and you start the time from the moment you pour the water into the pot, it may be a whole lot different if you start the 30-minute time on the moment that the water boils. Plus there's a difference if the instruction is like 'You boil the leaves with 2 cups water until the point that the water remaining is only 1 cup.'
• The time of the day when you pick up a leaf/root/bark matters. We had been advised that the perfect time to pick leaves is in the morning just before the sun rises as the leaves has the perfect consistency to it.

These are just the few things that affects a certain preparation of a herbal medicine and we had been told that there are still a lot of considerations to think of as certain alterations to these may affect the therapeutic effect of the preparation itself.

When it comes to commercially prepared "Food Supplements" in the market that has a label of 'No therapeutic use' in its packaging, let's discuss some important aspects:

• Food supplements. As they are labelled food supplements, they should be treated as such. Meaning a food supplement is just that, a supplement to food. It SHOULD NOT BE TREATED AS A MEDICATION. It was approved as something that could supplement a certain vitamin or a mineral that is missing in food. Meaning eating a certain food is not enough so you drink this products to SUPPLEMENT the said nutrient.
• FDA approved. This products are well advertised in radio and televisions as something that is approved by a government agency (FDA or the Food and Drugs Administration) and somehow gives credence to its use. I say IT DOES NOT! Again they are approved AS FOOD SUPPLEMENTS! NOT AS MEDICATIONS! And so, THEY SHOULD NOT BE TREATED AS A MEDICATION (if you haven't noticed my emphasis on this point, I don't know what will drive home the point).
• No Approved Therapeutic Claim. This label is mandated by the government to be put in the packaging of these products to emphasize that the product contains 'NO APPROVED THERAPEUTIC CLAIM' meaning there are no good or positive effect derived from it. This point seems to escape the senses of some so the government resorted to translating this phrase into the vernacular which is "Ang produktong ito ay HINDI GAMOT, at HINDI PUEDENG IPANGGAMOT SA ANUMANG URI NG SAKIT." But I guess to drive home the message, let me translate it further to cebuano/bisaya - "Ang produkto nga ini, DILI TAMBAL, ug DILI PUEDE IPANGTAMBAL SA BISAG UNSA NGA SAKIT."
• Advertising Gimmick. As this phrase was already mandated by the government to be included in advetisements in radio and televisions but not everyone seems to notice it, let me point you out to the reason why. After each advertisement in TV, you can still see see the said note: 'Ang produktong ito ay hindi gamot at hindi puedeng ipanggamot sa anumang uri ng sakit.' but the size of the text is so small that you have to use a magnifying glass to read it and they flash it to about 1-2 second so before you even finish reading it, it's gone already. Same thing in the radio, they cram the whole phrase into 30 seconds that you can't understand what the annnouncer is talking about.
• These products should not be treated as MEDICATIONS. During our pharmacology classes, we have to learn all about pharmacokinetics, pharmacodynamics, and everything about medications. It is at that time also that we have learned that a certain Drug/Medication takes about 9.5-15.5 YEARS before it can be approved for commercial use and be available in drugstores/pharmacies. Why do you ask it takes that long for a new medication for commercial use? - Because a certain drug undergoes 5 stages of development before it can be available for commercial use. These stages are the following:
1. Early Drug Discovery (2-5 Years) - This is where Target Selection, Lead Finding, Lead Optimisation and Pharmacological Profiling is done. Meaning this is the stage wherein we identify the Product/Substance that we want to study as a possible candidate for approval as a medication.
2. Preclinical Studies (1.5 Years) - refers to the stage wherein Pharmacokinetics, Short-Term Toxicology, Formulation, and Synthesis Scale-Up is done. Meaning this is the stage wherein the candidate product is studied for its toxic properties, the relative effects of the candidate product if introduced into the body, what are the formulation or preparations that the candidate product is most effective if introduced into the body.
3. Clinical Development (5-7 Years) - Has 3 Phases and these includes Phase I (Pharmacokinetics, Tolerability and Side-Effects in Healthy Volunteers are being studied), Phase II (Small Scale Trials in Target Patients to Assess Efficacy and Dosage and Long-Term Toxicology Studies are done) and Phase III (wherein Large-Scale Controlled Clinical Trials are done).
4. FDA Review (1-2 Years) - wherein Submission of Full Date and Review by Regulatory Agencies such as the Food and Drug Administration.
5. Post-Market Monitoring - is the stage wherein the pharmaceutical company monitors for other drug side-effects or adverse effects to patients that are not noted during the Clinical Development Stage
• The reason why Food Supplements SHOULD NOT BE CONSIDERED AS MEDICATIONS. Maybe you're wondering why I felt the need to discuss the Stages of Drug Development? It is because this Stages determine the process that a certain drug undergoes before it can be approved as a MEDICATION. Meaning this process separates the MEDICATIONS from the FOOD SUPPLEMENTS as Food Supplements DOES NOT undergo these processes. In other terms, a certain Medication is very well studied for its dosage, effects, side-effects, adverse effects, drug interactions and so many other things while a Food Supplement DOES NOT undergo any studies for the criteria I have mentioned earlier. Meaning there may be undiscovered side-effects or adverse effects of a certain Food Supplement if these are ingested or taken by a patient.
• Anecdotal Evidence. The companies that promote these Food Supplements use anecdotal reports or patient experiences to prove its "positive effects" to the body and also to prove its alleged "efficacy". But experience taught me that anecdotal experiences of patients usually differ from person to person meaning what may be a good effect to a patient may not be the same effect to another patient. Also, my experience in taking care of patients also taught me that when it comes to Food Supplements, only those "positive effects" are discussed or promoted to other patients in order to encourage them to use such Food Supplement while those "Negative Effects" are often forgotten or disregarded. The reason for this may be due to lack of medical knowledge, ignorance of the said negative effects or plainly deliberate denial of the presence of such negative effects. One Negative Effect that I may annecdotally present (there is no formal studies conducted to prove this) is the incidence of KIDNEY FAILURES for patient who have history of Food Supplements use. As my colleagues in the Internal Medicine Department would attest, most patients who have Kidney Failures most likely will have history, one way or another, of food supplement use.

And so the take-home message of this post is: PATIENTS SHOULD NOT RELY OR USE FOOD SUPPLEMENTS TREATING THEM AS "MEDICATIONS".