**Butler, Jennie C**

**From:** Williams, Carole A

**Sent:** Thursday, April 06, 2000 10:03 AM

**To:** Butler, Jennie C

**Subject:** FW: My comments

Jennie:

Andrew Baer\'s oral comments are attached.

\-\-\-\--Original Message\-\-\-\--

**From:** Andrew M. Baer, MD \[SMTP:drbaer@integrativemedicine.com\]

**Sent:** Wednesday, April 05, 2000 1:59 AM

**To:** Williams, Carole A

**Subject:** Re: My comments

Dear Ms. Williams,

During the time I was making my comments, someone\'s cell phone started

ringing. It was not immediately answered and persisted in ringint. It

disrupted the panel by breaking its attention and it had the same effect

upon me. Speakers had only five minutes to talk.

As a consequence, I becme a bit flustered and was unable to finish
reading

my comments. As we were behind anyway, I did not request a chance to
begin

again or finish my comments. I got the sense they would not have
permited

it.

So, I am asking that my comments be added to the record manually. I have

attached them to this email in Microsoft Word format. I would appreciate
it

if you would let me know if you were able to accomplish this for me.

If you cannot, please forward the email and attachment for me or let me
know

to whom I might send it.

Thank you.

Sincerely,

Andrew M. Baer, MD**\
**

**Comments Made At April 4^th^ FDA Public**

# Meeting by Andrew M. Baer, MD

My name is Dr. Andrew Baer. I am an Internist practicing Integrative
Medicine. I am a Medical Advisor and Consultant to the Life Extension
Foundation.

What are the real core issues here? They are the safety and efficacy of
dietary supplements. However, the will of congress promulgated in DSHEA
was that dietary supplements do not fall into the same category as drugs
and therefore are not subject to the same approval process of safety and
efficacy. *Pearson v Shalala* opens up this Pandora's box yet again as a
first amendment issue.

Despite the fact that the judiciary ruled in favor of Pearson in January
1999, the FDA has the audacity to seek public recommendations regarding
the very issue the courts have already decided. Even though the debate
here is therefore moot on the basis of the first amendment court
findings, let us look at the issues from another perspective.

Attempting to subject dietary supplements to the same approval process
as drugs would be prohibitively expensive. It would be impossible to
pass research and approval costs on to the consumer because the public
would not buy supplements at such a highly inflated price. Moreover,
medical insurance does not cover the cost of dietary supplements at
their present cost. They surely would not do so at one inflated by
research and approval costs. More importantly, why reinvent the wheel.
The majority of dietary supplements have a long track record of safety
in other countries. Safety is the only legitimate concern. Efficacy of
dietary supplements is another issue entirely and will be discussed
subsequently.

The FDA\'s attempts to guarantee both safety and efficacy of approved
drugs have often failed. The disaster of thalidomide was in part
responsible for the development of the FDA's approval paradigm.
Ironically, thalidomide is back on the medical scene with potentially
new indications. The FDA approved H2 blockers for the treatment of
peptic ulcer disease. Now we know that the etiology of this disease is a
biological agent. Yet, H2 blockers remain on the over the counter
shelves despite their potential injurious nature. Normal digestion takes
place at an acid pH in the stomach. Raising pH leads to inadequate
digestion with partial cleavage of proteins resulting in digestive
protein remnants finding their way into the small bowel. Here, patients
with leaky gut are likely to absorb these remnants which act as antigens
stimulating T cells often resulting in T cell mediated allergy leading
to auto immune disease.

The Coronary Artery Bypass Graft was never double blinded. It is
immensely popular and a cottage industry for hospitals despite the fact
that it remains, except in a few instances, an expensive treatment for
anginal pain. In the 1960s, a study, which would never be done today,
involved the ligation of the mammary arteries as a treatment for angina.
Sham surgeries were performed on patients where the patient's chest was
cut but the mammary artery ligation not done. The other group had the
real surgery with mammary artery ligation. There was no statistical
difference in anginal pain relief in the two groups.

Phen-Fen was another disaster; not because it was withdrawn but because
it was withdrawn too soon. The percentages of valve problems turned out
ultimately to be much smaller than originally thought. Who suffered
because of this? The morbidly obese who are desperate for help. The cost
benefit was in favor of maintaining that drug combination's
availability. The only winners are the lawyers who were quick to get on
the scene with class action suites against the manufacturers of
Phen-Fen's constituent drugs.

What does all of this suggest? The drug approval process is imperfect.
Medicine represents a dynamic, ever changing body of knowledge. Today's
wonder drug may be tomorrow's poison. So, from a practical standpoint,
is the public really served by subjecting dietary supplements that we
already know to be safe because of their track record in other countries
to this same very unpredictable, problematic and costly process? Of
course the panel discussions were about another way.

The same dynamism that applies to medicine and drug safety and efficacy
obtains with dietary supplements. The panel debates around disclosure
and the FDA's mystical standard of a significant scientific agreement
would suggest a problem generated from the studies which equally divide
among positive and negative. Rather than this being a problem and viewed
as inconclusive one should see this as another reflection of dynamic
nature, and the fact that information will evolve over time.

The FDA is not jumping up and down over the fact that H2 blockers once
thought to be efficacious in the treatment of peptic ulcer disease are
no longer viewed this way. Why should a dietary supplement once viewed
as effective or possibly effective and found not to be, be treated any
differently?

This brings us to the real issue. A few months ago the Washington Post
published an article about a study suggesting that couples who sleep
with their infants put their infants at risk for smothering. The
Founding Fathers either in the Federalist Papers, the Constitution, or
in other writings, never envisioned our country to have a government
that would attempt to create a risk free society in which no untoward
events ever occurred. Yet, that is exactly what the paternalistic
government bureaucracies attempt to do; insinuate themselves into our
daily lives by creating regulations that stifle, choke, and restrain all
in the interest of protecting people from themselves.

It is in this context that the FDA and FTC would insinuate themselves
into our lives to protect us against fraud. In the grand scheme of
things does it really matter if a dietary supplement which purports to
do something fails to do so? Does it matter if this is either in disease
prevention or treatment? I think not. Nobody ever said that life was
perfect and risk free. As imperfect as the FDA's attempts are to protect
us from unsafe and non-efficacious drugs are, in the end, the consumer
must remember the words, *caveat emptor.*

A cancer patient makes a choice to forgo traditional cancer chemotherapy
and takes a dietary supplement eventually dying from their disease. One
day it becomes known that the dietary supplement is non-efficacious,
does this require governmental intervention? I think not. Bad things
happen despite our best attempt to control them. People get cancer and
people die despite heroic efforts to treat them with chemotherapy.
Government cannot legislate or regulate an environment that is without
risk. That's life.

So, let us for arguments sake say we decide to begin labeling dietary
supplement bottles with information reflecting a summary of all the
studies to date. Do we really want the label to look like and be as
extensive as a page in the Physicians' Desk Reference? Why is it that
prescription bottles do not have the entire PDR description on them? The
reason is that physicians do informed consent and decide how much of
that information is relevant and should be given to the patient so that
patient can make an informed choice. The PDR represents every possible
untoward event even if it occurred only once in a million
administrations and may indeed not actually be related to the drug
itself. Informed consent is **intelligent** informed consent reflecting
the physician's medical expertise and judgement.

As an example, it is questionable whether or not the public is best
served by being told that one in ten thousand surgical deaths is on the
basis of receiving a general anesthetic alone. It is perhaps better to
just tell the patient that general anesthesia administration is not
without risk. All people are not intelligent enough to interpret medical
information that is why they see and depend upon a physician to provide
such information.

When it comes to evaluating articles written about dietary supplements,
is the entire public capable of evaluating the studies themselves.
Perhaps this is another reason for discussing dietary supplement use
with a physician. However, to say the public is totally incapable of
making these judgements is also wrong.

Perhaps the only information on a dietary supplement bottle should be
established indications and possible tonicities and the supplement's
interactions with drugs or other dietary supplements.

The public can seek out a physician or other professional for more
information, look in references or on the Internet just as can be done
with a drug. If the patient wants the detail available in the PDR, that
information is also available. It is a given individual's responsibility
to decide if he or she is capable of interpreting and making use of this
information. Again, *caveat emptor*.

When the FDA decided it was time to take acupuncture needles out of the
investigational new device category I remember thinking, "what
unmitigated hubris." The Chinese have been using acupuncture
successfully for thousands of years and do not require its acceptance by
the FDA or anyone else for that matter. The Chinese practice Eight
Principle Medicine, which treats patients with herbal combinations. The
Chinese have been doing this as well for thousands of years. Moreover,
they have done so without a regulatory body's approval. As for safety
and efficacy, we know there are billions of Chinese on the planet. They
are not dropping like flies from ingesting herbs. They must indeed be
doing something right.

All of this suggests one simple fact. The public really does not need
the FDA; not for drug or dietary supplement approval, period. If the FDA
continues to refuse to obey the law and drag its feet on *Pearson*, the
public may respond by pushing elected representatives to either
dismantle or otherwise curtail the FDA's mandate.

Additionally, dietary supplement use, particularly anti-oxidants have
become the standard of care in the medical community. I personally know
Cardiologist and other physicians who recommend dietary supplements to
patients.

If the FDA continues to prohibit physicians from making dietary
supplements recommendations it puts physicians at risk for litigation
from patients deprived of this information. Since the FDA in this
instance is responsible for prohibiting physicians from disseminating
dietary supplement information, it might be subject to litigation as
well.

I realize that in asking the FDA to obey the law and respond to the
court's findings in *Pearson* I am essentially asking it to voluntarily
abdicate its perceived authority over dietary supplements. Furthermore,
I know this is like asking a lion to stop eating meat. However, it only
need be said that, "the times they must be a changin," because I think
the FDA staff is starting to eat vegetables.

The following letter was sent to the Life Extension Foundation by a
member who requested that it be read and entered into the record:

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