Government Reform and Oversight Committee
February 12, 1998
Representative Peter DeFazio (D-Oregon)
Thank you, Mr. Chairman, Mr. Waxman and members of the committee
for giving me the opportunity to testify before you this morning.
I would like to state for the record that I am not here to
discredit or undermine the mandate of the FDA, NIH or the
NCI. Nor am I here to advocate for a particular medical modality
or interest group.
To me, the issue is very clear. Patients all over this country
are being denied access to beneficial health care treatments
by our government despite significant consumer demand. These
treatments are readily available in Europe and elsewhere.
In 1993, the New England Journal of Medicine found that one
out of every three Americans are using some form of alternative
medicine.
A recent nation-wide study conducted last November by Interactive
Solutions on behalf of Landmark Healthcare Inc, an HMO found
that over 42 percent of American consumers use some form of
alternative medicine. 67 percent surveyed believe that the
availability of alternative care is an important factor when
choosing a health plan. The background memo prepared by the
minority staff of this committee stated that over 80 percent
of American consumers have used some form of alternative medicine
at least once in their life-time.
A wide range of treatments are being used by millions of
American consumers but will not be researched or certified
in an official manner. Most of these products are not patentable
in the U.S. because they are made from essential nutrients
and other natural substances.
Sadly, none of these products are compatible with the current
FDA approval process because the system is only designed to
give approval to pharmaceuticals. Natural medicinal products
should be offered a separate approval track similar to the
one used in Germany, where manufacturers submit their product
for approval and undergo a different set of scientific reviews
for safety and efficacy. American consumers in growing numbers
are using these products regardless of whether they are approved
or not. Its time for the FDA to develop a two track approval
system one for natural medicine and one for commercial pharmaceutical
products and devices to meet consumer demand.
THE GERMAN MODEL FOR APPROVAL OF HERBS AND NATURAL SUBSTANCES.
* Commission E in Germany uses an approval process for medicinal
herbs and phytomedicines that is separate from the conventional
medical process. It is used to approve medicinal herbs and
phytomedicines. Manufacturers and medical researchers are
able to get approval for their plant-based medical products
without having to submit to the extraordinary rigors, requirements,
conditions and huge expenses needed for the approval process
for pharmaceuticals.
* The Commission is composed of an expert panel of physicians,
pharmacists, pharmacologists and biostatisticians. It is the
German government's equivalent of the FDA and is charged with
reviewing plant-based products based on bibliographic literature
that is actively gathered. This bibliography contains information
on chemical data, pharmacology, toxicology, clinical studies,
traditional and historical use, epidemiological studies and
patient case records. Members of the Commission assess this
data on a doctrine of absolute certainty for safety but reasonable
certainty for efficacy.
* This bibliography is used as a guide to consumers, doctors,
pharmacists, professors and practitioners. Over 70 to 80 percent
of general practitioners prescribe herbal medicine approved
by the German government.
* Statutory language contained in the Dietary Supplement
Health and Supplement Education Act (DSHEA) authorized the
creation of a Presidential commission on dietary supplements.
This past November, the commission recommended that the FDA
review herbs for possible approval as over the counter drugs
(OTC), which alluded to the Commission E model in Germany.
THE BENEFITS GARLIC IN TREATING HIGH CHOLESTEROL LEVELS.
* A recent study published in the American Journal of Clinical
Nutrition demonstrated that cholesterol levels may be reduced
when taking both fish oil and garlic. This basic nutritional
combination contains significant health benefits to individuals
suffering from high blood cholesterol levels. For centuries
garlic has been used as a natural antibiotic and a powerful
immunostimulant. This simple and low cost combination has
the potential for preventing curable conditions and could
be used as an alternative to commercial products. Unfortunately,
it will never be approved under the current process.
TREATMENT FOR BPH: THE COST AND SIDE EFFECTS OF SAW PALMETTO
VS. PROSCAR.
* There is a significant amount of evidence indicating that
saw palmetto, pumpkin seed extract and an herb called Pygeum
Africanum are far safer, less costly and more effective that
the current, FDA-approved allopathic treatment for an enlarged
prostate due to benign prostatic hyperplasia (BPH).
* This condition afflicts one in every 11 American men per
year. The current FDA approved treatments for BPH are Proscar
or finasteride. Both treatments costs around $75 per month
and can cause dangerous side effects such as impotence, insomnia,
urinary track complications and urogenital birth defects.
* According to Lanh Green, Diane Wysowsi and Jean Fourcroy
of the FDA, Proscar also causes gynecomastia, which is excessive
development of the male breast. This condition is also known
to cause breast cancer in men. Merck, the manufacturer of
Proscar grosses more than $1 billion in sales annually for
the product.
* Numerous medical studies conducted throughout Europe demonstrate
that the extract of saw palmetto (serena repens) is far safer
and more effective in reducing pain and swelling in the prostate
than both allopathic treatments approved by the FDA. There
are no known side-effects associated with saw palmetto and
it is widely used around the world. It was rejected by the
FDA even after its efficacy was proven through numerous clinical
trails. The FDA reported that these results were statistically
significant but denied the health claim because the results
were not medically significant.
THE BENEFITS OF TREATING DEPRESSION WITH ST. JOHNS WORT
OVER PROZAC.
* St. Johns Wort is the preferred therapy over pharmacological
medication for mild depression in Germany. It is reported
to enhance the immune system, increase antiviral activity
and relieve seasonal affective disorder. The British Medical
Journal published an overview of 28 clinical trials in 1996
conducted by Ludwig-Maximilian University in Munich which
confirmed that in 1,757 patients St. Johns Wort was as effective
as commercial antidepressants. The studies also noted that
the herb produced minimal side effects.
* Prozac, the preferred alternative to St. Johns Wort in
the U.S., is known to cause nausea, anxiety, insomnia, diarrhea,
dizziness, headaches, sexual dysfunction, and difficulty with
concentration. St. Johns Wort also costs about $10 per month
whereas Prozac costs, on average, $80 per month. In Germany,
the leading St. Johns Wort product outsells Prozac by seven
to one.
* NIMH in conjunction with OAM will be conducting a four-month
double-blind study of 330 patients on the effectiveness of
St. Johns Wort in treating clinical depression compared to
Zoloft and a placebo. The coordinating research site will
be Duke university. The study will cost $4.5 million and it
will come out of the OAM budget.
THE BENEFITS OF USING VALERIAN ROOT OVER HALCYON.
* Valerian root is commonly used all over the world as a
sleep aid. It is also used to treat fatigue, jet lag, nervousness
and is an approved therapy in France, Germany and the U.K.
Valerian has also been listed in the European pharmacopeia
since 1973 and has been proven safe and effective in numerous
pharmacological studies. Several double-blind clinical studies
have proven the benefits of Valerian root in improving sleep
quality.
* In 1994, the European American Phytomedicine Coalition
submitted a citizens petition to the FDA for approval of Valerian
as a night time sleep aid. To date, their petition is still
pending and they haven't received a response from the FDA
regarding the status.
* Halcyon, the FDA approved, pharmaceutical counterpart to
Valerian, contains benzodiazepine which is known to cause
nausea, dizziness, insomnia, panic, depression, headaches,
anxiety, and deprives patients of REM sleep which disrupts
normal sleep patterns.
* When I came to Congress in 1986, Halcyon was commonly prescribed
to Members of Congress for jet lag and sleep disorders. Halcyon
was also the substance that was implicated in the incident
where former President George Bush vomited at an official
dinner hosted by the Japanese Prime Minister.
ACUPUNCTURE ONCE CONSIDERED "QUACKERY" NOW A LEGITIMATE
MODALITY ENDORSED BY A GROUP OF PHYSICIANS SPONSORED BY AN
NIH COMMITTEE AND CHAIRED BY DR. DAVID RAMSEY, PRESIDENT OF
THE U. OF MARYLAND MEDICAL SCHOOL.
* The history of acupuncture in the U.S. demonstrates the
inflexible bias of the mainstream medical community even after
it was widely accepted by American consumers. Acupuncture
has been used by one fourth of the world's population for
the last 2500 years. However, in the U.S. it was considered
"quackery" by a majority of physicians and surgeons until
recently.
* In a recent NIH consensus development meeting, a 12-member
committee of independent doctors and scientists determined
that acupuncture was a satisfactory treatment for chronic
pain, vomiting and nausea related chemotherapy, nausea from
pregnancy and postoperative dental pain, back pain and post
stroke care.
* A report published by the NIH committee on acupuncture
stated that "while conventional medical practices are often
thought to be utilized because there is substantial research
evidence to support them, this is frequently not the case.
But this does not mean that these treatments are not effective.
The data in support of acupuncture are as strong as those
for many accepted Western medical therapies."
* According to the American Cancer Society information database,
acupuncture is described as "simple and often works. It has
few side effects or complications and the cost is low. For
these reasons, it can be a good choice for some problems that
have no underlying cause which can be treated.
A CALL FOR ACTION ON THE PRACTICE OUTCOMES MONITORING
AND EVALUATION SYSTEM (POMES).
* This summer, the OAM and the NCI convened a meeting called
the Practice Outcomes Monitoring and Evaluation System (POMES)
to consider how to better evaluate the practices of doctors
who use unconventional methods to treat cancer. However, most
of the participants of the meeting were puzzled and somewhat
discouraged by the lack of attendance among the top FDA and
NCI officials, especially since the meeting was sponsored
by NCI. Dr. Klausner, Director of NCI and his Deputy, Dr.
Wittes were both absent from the meeting.
* A consensus was developed at the meeting that called for
the creation of an Oversight Board led by a body of experienced
medical professionals that would help guarantee a level playing
field for research in the area of alternative practices. Unfortunately,
since the meeting, NCI and NIH has done nothing to facilitate
the consensus decisions that were made. I urge the committee
to put pressure on the NCI to follow through with the POMES
meeting.
GENERAL FACTS ABOUT CANCER.
The NCI has spent over $10 billion in research over the past
five years, yet cancer patients are still left with the same
limited treatment options such as radiation, chemotherapy
or surgery -- all very costly and physically debilitating,
and there has been little increase in life expectancy during
that time period. Very little has changed in the last 20 years.
Let's take a look at some well-known facts:
* Roughly 1.5 million Americans are diagnosed with cancer
each year.
* By the year 2000, two out of every five Americans will
be diagnosed with some form of cancer.
* I ask my colleagues, why are we spending so much taxpayer
money exclusively on conventional medical research when we
have so little to show for it. I would urge my colleagues
to request the NCI to begin to conduct studies on alternatives
that are being used by practitioners and doctors in the U.S.
and around the world. It seems to me that we aren't being
fiscally responsible in our fight against these deadly cancers.
BREAST CANCER
* In 1962, over 63,000 women were diagnosed with breast cancer
* In 1971 when President Nixon launched the "war on cancer,"
this number reached 69,000, and a woman's lifetime risk of
contracting breast cancer was one in fourteen.
* Since 1960, nearly 2 million American women died from breast
cancer. This is an outrageous figure and yet the NCI and the
NIH still spend billions of taxpayer dollars. This level of
mortality is not acceptable and the NCI and the NIH should
spend a portion of their research funding on researching promising
alternative therapies
WHAT IS WRONG WITH THE CURRENT FDA DRUG APPROVAL PROCESS.
* According to a report by the Office of Technology Assessment
(OTA), the FDA approval process costs an applicant over $500
million dollars and about 8 to 12 years before a new drug
receives approval.
* I ask my colleagues, does it make sense for a medical researcher
who is not affiliated with a multinational pharmaceutical
company to seek FDA approval for a product if they cannot
obtain a patent for it? If their product is non-patentable
they are unable to recoup the financial losses involved with
seeking approval. How could they ever expect to obtain FDA
approval if they cannot obtain the amount of capital involved?
The answer is that many manufacturers and medical researchers
do not seek approval due to these cost barriers.
* In his testimony before the House Commerce Committee on
September 23, 1997, Dr. Michael Friedman, the Lead Deputy
Commissioner of the FDA expressed the same concerns. He said
that "collectively we need to address how to promote research
on possible effective remedies where market incentives may
not work."
* Our current system still forces many Americans to seek
treatments outside the U.S. Patients are also forced to obtain
medications without any official monitoring or content review.
This leaves chronically-ill patients with no other choice
but to circumvent the law by obtaining treatments which are
unapproved.
WHAT IS WRONG WITH THE FDA REFORM BILL THAT PASSED LAST
YEAR?
* Despite claims to the contrary, the FDA modernization act
provides no new mechanisms for expanded patient access to
investigational drugs and therapies. Instead, the Act continues
to let the FDA make the final word on whether a seriously-ill
patient receives access to an investigational drug despite
the pleas of doctors, scientists and other medical professionals.
Specifically, Section 561 of the Act:
1) requires FDA to conduct a detailed and time-consuming
administrative review for chronically ill patients seeking
alternative treatments in emergency situations.
2) permits the FDA to second-guess the judgement of attending
physicians and scientific experts regarding the safety and
efficacy of an unapproved treatment, thus enabling the government
the last word in denying patient access.
After reviewing the provisions in this Act, I am amazed that
my colleagues remain convinced that this bill provides all
the access necessary to critically ill patients and their
families. I choose to stand with patients and families who
are fighting for fairness and low cost, effective treatment
options that are currently absent from our health care delivery
system. It is time for our government to defend the rights
of American patients and consumers. The discussion of a consumer
bill of rights, which is not within this committees jurisdiction,
should correct the flaws of the FDA modernization bill.
I urge you all to remember the words of one of our great
leaders, a crusader for fairness and freedom, Abraham Lincoln
when he said "the legitimate object of government, is to do
for a community of people whatever they need to have done,
but cannot do for themselves in their separate individual
capacities. In all that the people can individually do as
well for themselves, government ought not to interfere." (Collected
Works of Abraham Lincoln July 1, 1854)
I look forward to working with this committee and the FDA
in making patient access to medical breakthroughs a reality
for millions of Americans.
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