No approved therapeutic claim

For the record, let me start with a disclaimer.

I am not against complementary alternative medicine (CAM).  They may have their roles in various health and illness.  But just because they are “natural” or “alternative” does not give them the territory of absolutely safety. While there may be a role for many CAMs, the need to prove that the benefits outweigh the risks is important. And coming out with well controlled studies are essential to demonstrate that it can actually cure and is treatment to a disease. Otherwise, their claims will always be supplementary at best.

The Food and Drug Administration evaluates medicines based on quality, efficacy and safety standards.  If they meet these criteria, then they are given marketing authorisation.

On the clinical aspect, a drug (or supplement or complementary medicine) to be useful must at best fulfill the following: suitability (need), efficacy, safety, and affordability. For those that are off patent, interchangeability standards are required.

Let’s use dry cough as an example.

Most herbal medicines apply their products as food during the registration process. The reason for this may be multiple in nature.

Doing robust clinical trials are costly. It’s important that they follow Good Clinical Practice and approved by an accredited Ethics Review Board or Institutional Review Board to ensure that no harm is unwarrantedly done in the proposed studies or that the benefit of conducting the trial outweighs other risks. They should, at the very least be able to demonstrate beyond reasonable doubt (statistically significant difference) that between the experimental agent and placebo and/or standard accepted therapy, the experimental agent works.

Even something as minor as dry cough, to claim that it works better than water or     drugs in the symptomatic relief can cost an arm and a leg to execute properly.

Most herbal manufacturers don’t have that kind of money OR refuse to part with that amount of money.  Because pharmacognostically, the herbal agent may have mucolytic property, they can claim that the preparation may exhibit the same therapeutic properties as conventional drugs. All they will need to do is to (a) claim it is food and/or (b) use an endorser or testimonials to market the product. As to whether it is ethical to use these avenues for registering a product for a specific claim – the rule of thumb they follow is – THE ROAD TO NO APPROVED THERAPEUTIC CLAIMS.

It is not a medicine.  It is not for the treatment of a disease.  It simply helps.  It is natural.  It is an adjunct or supplement.

The second reason is proprietary ownership. CAM is a multibillion billion dollar business.  Grand View Research Inc. reported on April 2017 that the CAM industry would be worth around $196.87 BILLION USD by 2025.  That’s about 6 years down the road for us.  CAM finds its path into chronic diseases – hypertension, diabetes, kidney problems, liver ailments, cancer, etc.  The push here is driven by the increasing cost of conventional medicines and the marketing drive to overall wellness using vitamins, supplements, minerals and naturopathy.  But since the ingredients used in many CAM products are plant and nature derived, the proprietary rights to sources that are natural from the get go make it easy to replicate many of these success stories on botanicals. In short, nature has no patent.

Natural agents will need to, however, demonstrate its purity and safety.  The consistency in the manufacture of these products from batch to batch, their stability, interactions between ingredients that can cause potentiating or harmful effects when mixed with other herbal products are some considerations when evaluating these products.

After all, not all roses will be the same, even if they come from the same root or stem. Even the leaves of one bush of rose will vary among themselves.

It is easy to see, how skeptical the CAM industry is in sharing their “trade secrets”.  After all, even with vitamin C alone, the sources are vast and evidently wide if you were looking at a basket of fruits alone.

Third is the business aspect of CAM.  With rules and ethical norms guiding the principles of marketing in the pharmaceutical industry becoming more important, the business of CAM is unregulated to this degree.  Food, after all, is something that one can easily concoct and sell, even on an underground basis.  Drugs require that all products are under the radar of every National Regulatory Authority.  But CAM usually escapes both the mind of the consumer and the distributor through their no approved therapeutic claim pitch.  Actors and actresses, media men, personalities and every Tom, Dick, and Harry are easily paid to claim that taking herbal agents have made them look more radiant, younger, become smarter, or even have a better boner during sex.

In addition, unlike drugs which are given 20% senior citizen and PWD discounts (and less 12% Value Added Tax), supplements are not covered with this entitlement.

Then there’s the extravagant extended claim that it’s a do it all “medicine”. By golly, it will attempt to address allergies even if it’s nothing but a purported immunomodulator. Allergic disorders are NOT an immunologic problem per se. And there are more of this kind of marketing. Grow taller, be brighter, achieve more are dreams we all chase.

Do they really work?

The problem with CAM is that they’re also easily adulterated.  Under the guise of a supplement, many products have been noted to have active ingredients of conventional drugs but are sold as supplements and natural products and claim to work “as good as the conventional drug and are safer because they are ‘natural’.”

There was news back in September 2016 where a local supplement for erectile dysfunction was noted to be adulterated with tadalafil, a conventional drug that is used for treating this disorder.  Some Chinese ointments and creams contain a mixture of steroids and other antibacterial or anti fungals and claim that it is a do it all topical agent for the treatment for skin problems. They find their way into the shelves of dubious unlicensed outlets but are sold through pyramidal schemes or online. Hence the need for even herbal products being regulated to some degree.

The gullible consumer is often convinced of the efficacy of a product from testimonials of friends and family. Their marketing push will always be “natural” is safe.

I often get the question from patients on which multivitamin preparation is best or what cough remedy is suitable for their child.  I answer always – food for the former, and water for the latter. Nothing comes more natural than that!

While some (if not many) of these herbal products actually benefit the patients who use it for a specific disease, the consumer is warned about the purity of the products that make a claim, especially those whose claims are superfluous.  In addition, it is always good to discuss treatment strategies with your doctor when you are taking CAM.  The physician should likewise read up on the field of CAM so that he/she can guide his/her patients toward total body wellness.

To first do no harm is not the purview of only one specialty.  It is, everyone’s business to make sure that it is not abused for financial remuneration alone.

Because profiting from something that doesn’t work – whether conventional or CAM – is harm on patients who buy a bottle or a pill of hope.

No approved therapeutic claim #PetPeeveStories

I have nothing against complementary alternative medicine. Let that be my disclaimer before you go on to reading this post. After all, there is a scientific basis for herbal products. I understand the general public that wants to use “herbal supplements” and other forms of complementary alternative treatment modalities (acupuncture, Ayurvedic Medicine, massage, etc) for either prevention or treatment of an underlying disease.

For the understanding of the reader, CAM or complementary and alternative medicine is the general term for health and wellness therapies not part of conventional Western Medicine. Complementary refers to treatment used alongside conventional medicine. Alternative refers to treatment in place of conventional therapy.

The focus of CAM is the person as a whole – emotional, physical, spiritual, and mental health. Natural products, also known as naturopathy, include herbs and dietary supplements.

With increasing use of CAM worldwide, the term Integrative Medicine has been preferred to describe the best of conventional care with the best of alternative medicines.

Sadly, while not a lot of patients understand what CAM is, the lack of knowledge and information by many doctors limits the integration into best clinical practice of CAM with conventional medicine. It is important in this equation that BOTH parties understand each other when using CAM as part of, or as a substitute for, conventional medicine.

The peeve in this issue is the misunderstanding of either parties about CAM.

Complementary therapies used alongside may help in the management of certain diseases. For example, marijuana in patients undergoing chemotherapy has beneficial properties on the nausea and vomiting side effects of chemotherapeutic agents. Instead of having to administer an anti-emetic agent, minimising more drugs which can result in drug to drug interaction may benefit select patients.

Like many other things in life, what may be good for the goose may not necessarily be applicable for the gander. Which means, that just because it works for someone, it is applicable to all.

Many alternative therapies lack controlled clinical trials. Clinical trials is the road taken by conventional medicines in order to support the claim of efficacy over placebo or other standard therapy. It is thereby encouraged that when looking for the evidence of efficacy and safety, clinical trials over testimonials are the rule rather than the exception.

Physicians are encouraged to learn about the benefits and risks of CAM, the science behind their development, and their uses and contraindications as well as potential drug interactions with conventional medicine so that when discussing it with patients who inquire about this issue, they can discuss on a cerebral level, its potential use and misuse with the patient.

Two important points should be cited here:

1. Physicians should not base their recommendation of CAM on financial gains by selling a product in their clinics, without appropriate information on the supplement.

2. Some doctors refuse to use it because they say the patient will not benefit from its complementary, alternative or integrative use not because there is truly no “approved therapeutic claim”, but because the doctor does not know what the product and the question is.

As physicians, the prime objective is to do no harm to patients. This includes assisting them in the various levels of care of their illness. Patients rely highly on recommendations of doctors. When the doctor shuns away information (valid or not) brought to his/her attention by patients who pick up a variety of information on the Internet, it is their responsibility to keep updated and assist the patient in arriving at a consensus in the management of the patient’s illness.

No one deserves anything less.

A friendly advice to patients, don’t believe everything on the Internet. It takes very little effort to sell something that can bring you harm. Discuss CAM with your physician or someone knowledgable in this first.