WHAT SHOULD WE BELIEVE?

Sifting through the claims

of herbal products
Cecilia Maramba-Lazarte, MD, MScID, MScCT
Director, Institute of Herbal Medicine
NIH, UP Manila
Utilization of Herbal Products in the
Philippines
12% used herbal products in the past year
among OPD patients consulting at a
private hospital
77% of diabetics in a government hospital
used herbal products
Cancer patients in PGH reported using
CAM, with herbal medicine as one of the
top modalities
 3 types of herbal products in the
Philippines

Herbal supplements
Traditionally used herbal products
Herbal medicines
 Herbal/Food Supplement
(PhiliFDA) AO 2014-029 Rules and
regulations on the Licensing of Food
Establishments and Registration of
Processed Food Establishment and other
Food Products and Food for other
purposes
 (AO 2014-0029)
Herbal/Food supplement
Processed food product intended to suplement
the diet that contains 1 or more of the following
dietary ingredient:
vitamin, mineral, amino acid, HERB or other
dietary substance of botanical, animal, artificial or
natural ingredient to increase the total daily
intake in amounts coming to the latest Phil RENI
Capsules, tablets, liguids, gels, powders, pills
Not represented for use as a conventional food or
as sole item of a meal or not a replacement for
drugs and medicine
 (AO 2014-0029)
Herbal/Food supplement
Documents to substantiate claims such as a
technical, nutritional claims such as
technical, nutritional or health studies or
reports, market research studies, etc
Shall not have curative or therapeutic claims
Advertising and promotional materials- shall
not make curative or therapeutic claims
without scientific data or clinical trials to
substantiate such claim
MAHALAGANG
PAALALA: ANG (name
of product) AY HINDI
GAMOT AT HINDI
DAPAT GAMITING
PANGGAMOT SA
ANUMANG URI NG
SAKIT.
Philippine FDA Definitions
Traditionally used Herbal Products/-
preparations from plant materials whose
claimed application is/are based only on
experience of long usage which should
be at least 5 or more decades as
documented in medical, historical and
ethnological literature
Traditionally used Herbal
Products/
Minimal evidence for safety and efficacy-
PhilFDA 2004 Guidelines
Documentation of prolonged and
permanent uneventful use of herbal
product
Absence of unsuspected potential for
systematic toxicity, carcinogenicity and
teratogenicty
Evidence for claimed application shall be
based on medical/ pharmaceutical
literature
Philippines FDA Definitions (AO2004)
Herbal medicines -finished labeled medicinal
products that contain active ingredient/s aerial
or underground part(s) of plants or any other
plant material or combination thereof, whether
in the crude state or as plant preparations.
Herbal medicines may contain excipients in
addition to the active ingredient
- Shall have specific therapeutic claim(s) and shall
be intended for use in the diagnosis, alleviation,
cure or treatment of disease, promotion of
health or intended to affect or modify the
structure or any function of the body of humans
or animals
 Herbal medicines
Evidence of safety and efficacy- PhilFDA AO 172
2004
1. Pre clinical- Acute LD50
Pharmacological effects both in vivo and in vitro
Bioassay
Non-mutagenicity- Ames test and micronucleus
test
sub-chronic and chronic toxicity
2. Clinical- for galenicals- Phase 1 trials
For dosage forms- Phase 1,2 and 3 trials
 Health Fraud Scams
Consumers spend billions of dollars on
health fraud scams
HEALTH FRAUD- (USFDA)
articles of unproven effectiveness that
are promoted to improve health, well-
being or appearance; it can be drugs,
devices foods or cosmetics for human and
animal use
- In all media; sophisticated marketing
 Risks of Health Fraud Scams
Waste your money
Can cause serious injury
Can cause death
- Can delay potentially life saving diagnosis
and medication that actually works
- Contain hidden drug ingredients that can
be harmful; heavy metals; other drugs
 Common types of Health Fraud
Scams
Claims related to:
Cancer, diabetes and HIV/AIDS- these
diseases require individualized treatment by
physicians
Arthritis remedies fraud
Weight loss
Anti-aging
Memory loss
Sexual performance
USFDA Website of Tainted Products
Marketed as Dietary Supplements
756 products listed
Lists only a small fraction of potentially
hazardous products with hidden
ingredients
USFDA is unable to test all products
marketed
 Dream Body Advanced + Acai
Weight Loss & Cleanse contains
USFDA laboratory analysis confirmed that sibutramine,
fluoxetine and sildenafil.
Sibutramine- controlled substance that was removed from
the market in Oct 2010 for safety reasons; caused HPN and
tachycardia
Fluoxetine- selective serotonin reuptake inhibitors (SSRIs)
used for treating depression, bulimia, OCD, panic disorder,
and premenstrual dysphoric disorder; side effects
including suicidal thinking, abnormal bleeding, and
seizures. In patients on other medications for common
conditions (aspirin, ibuprofen, or other drugs for
depression, anxiety, bipolar illness, blood clots,
chemotherapy, heart conditions, and psychosis),
ventricular arrhythmia or sudden death can occur.
Sidenafil-drug Viagra, used to treat erectile dysfunction
1. One product does it all claims to
cure a wide range of diseases
 2. Personal Testimonials
it cured my diabetes; my tumors are gone
- easy to invent
Alzheimers Disease!!
My husband has
Alzheimer. He began
eating 1 tsp of Pure
Emu Oil each day
Now in 22 days, he
mowed the grass,
cleaned out the
garage, weeded the
flower beds and took
his morning walk.
 Tip off-personal testimonials
Can be completely made up or untrue
Weakest form of scientific validity
Benefits may be due to remission in
disease
Benefits may be due to earlier or
concurrent use of approved medical
treatment
Rather than use of the fraudulent product
 6 Tip-offs to Rip-offs
best evidence: Need actual randomized, blinded
clinical trial
This is the requirement for medicines to be
registered (Phase 1, Phase 2 and Phase 3 Clinical
Trials)
 3. Quick fixes
- Lose 30 pounds in 30 days!
- Cures diabetes in minutes!
US Federal Trade Commission Bulletin
Of the 11 complaints the FTC announced today, six
have been resolved by proposed settlements; the rest
will be litigated.
companies will be required to notify consumers who
purchased the products challenged in the complaints
that there was little or no scientific evidence
demonstrating the products effectiveness for
treating or curing cancer.
They also must urge these customers to consult with
their doctors about the products.
companies will be prohibited from selling or
disclosing their consumer lists to others.
include essiac teas and other herbal mixtures,
laetrile, black salve (a corrosive ointment), and
mushroom extracts.
US Federal Trade Commission
Bioque Technologies, Inc. The
respondents marketed an extract from the
soursop or guanabana tropical fruit tree and
claimed in their advertisements that it could
prevent and treat melanoma. They also
represented that the product, called Serum
GV, was clinically proven to do these things.
Under the proposed agreement, the
respondents are required to pay the full
amount of Serum GV sales, $9,035.85, in
consumer redress.
 Graviola and cancer
Overall-no evidence to show that graviola works as
a cure for cancer.
Graviola extracts from the leaf, fruit, and seed have
been tested in laboratories for their anticancer
effects. Some studies show these extracts to be
active against breast lung ,colon , prostate, pancreas,
liver, and skin cancer cell lines. However, graviola
products have not been studied in cancer patients.
Consumption of graviola has been associated with
adverse effects. Alkaloids extracted from graviola
may cause neuronal dysfunction and degeneration
leading to symptoms of Parkinsons disease .
Graviola may decrease the uptake of
radiopharmaceuticals used in nuclear imaging and
lower platelet counts .
 6 Tip-offs to Rip-offs
4. All NATURAL
- natural is not equivalent to safe
poisonous plants, mushrooms
USFDA has found numerous products which
are all natural but are contaminated or have
high doses of prescription drugs
 6 Tip-offs to Rip-offs
5. Miracle cure
New discovery
scientific breakthrough
secret ingredient
- if it were a true breakthrough it would be
widely reported on media and prescribed
by health professionals
- not on print ads, pop-up ads on the
internet or infomercials
 6 Tip-offs to Rip-offs
6. Conspiracy theories
The pharmaceutical industry and the
government are working together to hide
information about a miracle cure.
-always untrue and unfounded; distract
consumers from common-sense questons
about the so-called miracle cure.
Red Flags- favorite phrases used
Miraculous cure! Natural Cure
Quick fix Shrinks tumors
Ancient remedy Quick and painless cure
New discovery No-risk money back
Scientific guarantee
Breakthrough No side effects
Secret ingredient
 Safety Considerations
Tell your doctor that your are taking a
specific supplement
Do not replace your maintenance
medicines with herbal supplements
If you are pregnant, breastfeeding, with
renal or liver disorder, about to have
surgery, take extra precautions; may
affect baby or cause interactions
How to use Supplements wisely
To use supplements safely, read and follow the label
instructions, and recognize that natural does not always
mean safe. Be aware that an herbal supplement may
contain dozens of compounds and that all of its ingredients
may not be known.
Some dietary supplements may interact with medications or
pose risks if you have medical problems or are going to have
surgery. Most dietary supplements have not been tested in
pregnant women, nursing mothers, or children.
. Food and Drug Administration (FDA) regulates dietary
supplements, but the regulations for dietary supplements are
different and less strict than those for prescription or over-
the-counter drugs.
Tell all your health care providers about any
complementary health approaches you use. Give them a full
picture of what you do to manage your health. This will help
ensure coordinated and safe care.
US FDA Fact sheet