The Brewing Bitter Controversy

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" not intended to treat, prevent, mitigate, cure or diagnose (diabetes) disease," said Leticia B. Gutierrez, Director of the Philippine Bureau of Food and Drugs (BPAD) in her position paper released August 29, 2003. Health Secretary Manuel Dayrit on June 23rd issued Circular 196-A series of 2003 where he "strongly advised all concerned to cease, desist and discontinue any endorsement ampalaya an alternative treatment for diabetes mellitus." I could not agree more with those two pronouncements, albeit much delayed than what I had anticipated.

As we have stated in this very column a couple of years ago, ampalaya "medications" (for diabetes) and all the other hundreds of so-called "food supplements" on the market claiming to cure a host of illnesses, were scientifically baseless, and unsafe. I even suggested that, on top of the conventional anti-diabetic therapy, eating the ampalaya vegetable itself by diabetics, was more natural, healthier, safer and a lot cheaper and made a better sense. And today, I still maintain the same negative sentiment about all these unproven "food supplements" in general, and not only about ampalaya tea and capsules and Noni juice and pills.

I am glad the government has finally initiated steps to protect the public against false claims by the makers of "food supplements." I hope it doesn't stop at ampalaya tea and capsules. Its about time the BFAD took a harsh and firm stand on these perpetrators and our Department of Justice ran after, fined and penalized, the makers of these ineffective and dangerous items flooding the market, for their unsubstantiated and fraudulent claims that their products are an effective treatment or a cure for various diseases and without adverse side effects.

First, Do No Harm

While it might be a bitter pill to swallow for some people, especially for the money-hungry entrepreneurs (creators, manufacturers, marketers, and dealers of the ampalaya "food supplement"), we have to face the fact that ampalaya derivatives (pills, tea, etc.), like the other "food supplements" on the market, have not gone through the required and much-needed rigorous standards of scientific testing that includes animal laboratory analysis, large double-blind studies and randomized clinical trials in humans. That is a fact. And we should not lose sight of this fact as we delve into this controversy. To do so would be to trivialize and denigrade the sanctity of the Hippocratic precept of primum non nocere (first, do no harm) in treating living beings, the basic tenet of the Hippocratic Oath which all physicians take as they are sworn into the practice of medicine.

What is Ampalaya?

Commonly called Bitter Melon or Bitter Gourd (paliya in bisaya, maraguso in waray, apalya in pampango, ampalaya in tagalog) and known scientifically as Momordica charantia, ampalaya is a very popular vegetable in Asia, tubular in shape like eggplants or carrots, green in color, with characteristic thick, heavy tortuous wrinkles, folds or ruffles on the skin, and has a likeable, and even "addicting," bitter taste to many people.

Circumventing the Law

The claim of some lay observers that eating ampalaya "lowered" blood sugar, albeit unproven, gave the idea for some apparently unscrupulous, dishonest and profit-oriented businessmen to manufacture the ampalaya tea and capsules, and to sell them to the unsuspecting public obviously as an effective treatment for diabetes.

To be within the law, or to navigate within its boundary, these clever people who want to make big bucks call their product, and "hide" it as, a "food supplement." The reason for this because for a substance to be approved as a drug, it has to go through a most stringent investigation and meet very strict criteria enforced by the BFAD. It is a lot easier to hide behind the classification "food supplements." And the same thing is true with the majority of the manufacturers of the so-called "food supplements" out there, victimizing the ignorant consumers, who, unwittingly, seem to enjoy "donating" their hard-earned money to these purveyors of deceit, whose bank accounts are swelling. The "food supplement" business is a mega multi-billion dollar industry. Simply put, these entrepreneurs are banking on consumer stupidity. And they don't really give a damn about people's health and lives.

The media blitz of infomercials by the makers of these "food supplements," which includes anecdotal testimonials of apparently paid "users" (all of which are medically unacceptable, and invalid as reliable scientific data), has resulted in what literally is a massive fraud, but one which a segment of the public take gospels of truth. It is indeed most unfortunate and a shame.

What is Diabetes?

Diabetes is a Greek word that means "excessive urine" and Mellitus is a Latin name for "honey." Put together, they describe the medical condition where the patient has blood "as sweet as honey" and excessive urine.

Diabetes Mellitus is a syndrome characterized by hyperglycemia (high blood sugar), glycosuria (sweet urine) and is caused by an impairment in insulin secretion/and or insulin action. Insulin is a hormone produced by the beta cells of the Islet of Langerhans in the pancreas and is responsible for glucose metabolism. When these beta cells are destroyed (by an auto immune process or by virus), the insulin production is diminished or halted, leading to the body's inability to metabolize glucose, thereby causing hyperglycemia (high blood sugar), the condition we call Diabetes Mellitus.

There are more than 300,000 Filipinos who suffer from Diabetes Mellitus. In the United States, there are about 16 million diabetics and about 1800 new cases are diagnosed each year. Type I Diabetes, used to be called Juvenile Diabetes, is insulin-dependent (the person's pancreas does not produce insulin), meaning insulin injection is needed to treat the condition. It is medically known as IDDM (Insulin Dependent Diabetes Mellitus, most commonly among persons younger than 30 years old associated obesity is not common. It accounts for 5 to 10% of all diabetics. Type II Diabetes is NIDDM (Non-Insulin Dependent Diabetes Melllitus), which can be treated by pills (sulfonyl ureas, antihyperglycemic drugs) rather than insulin, most commonly found among those who are older than 30, and associated obesity is frequent. It accounts for majority (90 to 95%) of diabetics. The third type is Gestational Diabetes.

Modern Therapy is Safest

Today, thanks to advances in modern therapeutics and technology, there are proven, effective and safe treatment regimen for diabetes. This evidence and outcome-based therapy has allowed diabetics around the world to live healthier, more comfortable, happier and more productive lives. Unless an alternative (herbal or otherwise) form of treatment, one that is genuinely scientifically proven, comes along, our current conventional management for diabetes mellitus is still the best, the safest.

For those who need insulin, the state-of-the-art method of administering insulin to these diabetic patients is by the use of an implantable insulin pump. The small device is implanted under the skin and the catheter connected to it is inserted into a vein. The computerized pump contains insulin in its chamber and delivers a precise dose of insulin at a preset time schedule. The insulin chamber is refillable. This pump replaces the stinging needle injection as a method of giving insulin.

Why the controversy?

The brewing and bitter (no pun intended) controversy about ampalaya tea and pills centers on the following: there is evident inference, actually more like a blatant claim by its manufacturer and dealers, that ampalaya tea and capsules are effective for the treatment of diabetes. Many patients have abandoned the conventional medications prescribed by their physicians and have opted to take the ampalaya preparations instead. The Philippine Diabetic Association, the Philippine Society of Endocrinology and Metabolism, the Institute for Studies on Diabetes Foundation and the Philippine Center for Diabetes Education have reported that patients who totally relied on these ampalaya tea and pills alone have developed serious complications, like chronic renal failure, disorientation, hypertension, severe dehydration, edema (swelling), elevated blood sugar and congestive heart failure.

There is no convincing evidence todate that ampalaya tea and pills are effective and safe for the treatment of diabetes, much less, provide a cure. No significant and valid scientific studies based on the required strict standard protocol on adults and children have been done to show the efficacy and safety, the proper dosing, various assay data, compatibility or reaction with common drugs, side effects on the genes, on the patient or on the fetus in a pregnant diabetic, etc. None of these information and data, which are essential, are available. We need valid scientific proofs, and I would be the first one to rejoice if ampalaya or other herbs are proven beyond reasonable doubt to be efficacious for any disease. Anecdotal and paid testimonials are worthless. Just about anybody will be willing to say just about anything for a fee. Only a valid scientific study will convince me that ampalaya tea and pills (and all the other "food supplements" on the market) are effective and safe for me and my patients. Like all physicians and health personnel who care, I would be remiss if I didn't genuinely think of and fight to protect, the health, safety and welfare of my patients, the readers of my column, and the public in general.

If the DOH reversed itself from an earlier circular (168-A, 1995), it was obviously not politically or personally motivated but purely dictated by proper medical rationale and professional ethics. But as I stated earlier on, the BFAD move could have been initiated much earlier, and the campaign, more complete, involving the DOJ. Let's hope this is not just a ningas kugon endeavor, either. We'll see.

In the meantime, I shall continue to enjoy my green tea from China and eat my favorite sauted ampalaya with succulent jumbo shrimp, a mouth-watering gourmet recipe designed by my wife herself, "for someone who is very sweet." And these reciprocal testimonials, by the way, are unsolicited and unpaid.

©2003Raoul R. Diez, M.A.O.D.