URGENT: Threat to Alternative Medicine by FDA 4 DAYS AWAY!

[JRob]

The following was written by Dr. Nicholas Gonzalez.

We have to act fast!


Dear Patients and Friends:

I am contacting you regarding an issue that requires urgent action.
Recently, the Food and Drug Administration presented "draft guidelines" for
the regulation of "Complementary and Alternative Medicine Products." I have
had an expert in health care legislation review the guidelines, which
unfortunately, if enacted, have the potential to eliminate much alternative
and nutritional medicine from the US - including my therapy. The way the
guidelines seem to read, physicians would be prohibited from making even the
simplest nutritional recommendations, even recommending whole grains for
example, under threat of criminal prosecution. The FDA seems to be claiming
that such recommendations, even if supported by the scientific literature,
constitute unapproved drug claims unless the food or nutrient has gone
through the expensive and laborious FDA drug approval apparatus. The
guidelines if enacted are draconian in nature, seem to call for criminal
penalties for basic dietary recommendations, and impinge on both freedom of
speech and freedom of choice in health care.

The FDA allows comments on the proposals: the deadline is April 30, though I
suspect they will still consider e-mails or faxes sent several days beyond
the deadline. It is important that you contact the FDA and express, calmly
and factually, your opposition to the proposals, and your reasons. Even
more crucial, you need to contact your two Sentators and Representative in
the House of Representatives. Express your opposition to the guidelines,
again, calmly and factually. If significant numbers of Senators and
Representatives get involved, we can stop this potential threat to freedom
of choice in health care.

To make the task easier, I have enclosed relevant portions from the expert's
analysis of the FDA proposal, which includes the email and fax numbers of
the FDA, as well as the appropriate links to learn who your Senators and
House Representative are. It is easy to email or fax them, mailed letters
are not recommended because they are slow in arriving and time is of the
essence.

I have also enclosed a letter I have sent to one of my own Senators, Senator
Clinton, as well as my letter to the FDA. You can simply download and send
these letters along with your own cover letter if you like, but you must
include a personal letter as well. All the information about the "docket"
number are at the top of my letters.

To read the health care expert's letter, and my two letters, simply scroll
down. I decided against attachments, which can trigger spam filters.

Note that the first "expert" letter also talks about the threat to
compounding pharmacies, which provide "bio identical hormones." This issue
can wait for another day. If you keep scrolling down, you'll get to the
portion on the FDA guildelines.

Sincerely,


Nicholas Gonzalez, M.D.

*******


Recent Government Activity Regarding the Regulation of
Complementary and Alternative Medicine and Natural Products
April 2007

When the election results of November were in and it was obvious that there
was to be a leadership change in both the House and Senate, I was asked what
these changes meant for the Complementary and Alternative Medicine and
Natural Products (CAM) community. There were reasons to be concerned, given
the pending Committee Chairman appointments, the community was in a
'watchful waiting' stance. We as a community needed to see how
administrators and legislators were going to play their hand and now they
have.

Anyone who has been involved in the field for any length of time knows well
that there are several individuals who have a well established track record
of being adamantly opposed to the currently regulatory structure of dietary
supplements and at times to preserving the freedom to access or offer CAM.
Old time opponents, Congressmen Henry Waxman and John Dingel and Senator
Edward Kennedy are now in positions of significant power as is Senator
Richard Durbin. Further, the FDA, feeling the shift in power on Capitol
Hill has become empowered as well.

Time to Act

The time for watchful waiting is over. Everyone who cares about maintaining
their rights to access dietary supplements and complementary therapies needs
to speak out. Two issues that garner your immediate attention:

Safe Drug Compounding Act of 2007
Draft guidance for industry entitled ``Complementary and Alternative
Medicine Products and Their Regulation by the Food and Drug Administration

A. Safe Drug Compounding Act of 2007 - Senator Edward Kennedy (D-MA),
Richard Burr (R-NC) and Pat Roberts (R-KS) have floated draft legislation
to the pharmacy and medical community regarding the regulation of
compounding pharmacies. has floated to a draft bill to the pharmaceutical
and medical trade associations. The rise in use of compounding pharmacies
in recent years to access bio-identical hormones has gotten the attention of
the pharmaceutical industry and the FDA. Both would like to restrict this
growing trend to personalize medicines. Pharmacies like the practice of
medicine are regulated at the state level. This legislation would
federalize the regulatory oversight of compounding pharmacies and place them
under the jurisdiction of the FDA. The end result of this legislation will
be two fold: (1) to restrict consumers access to personalized medicines and
(2) to restrict the practice of compounding pharmacy. Even organizations
that are supportive of increasing the oversight of compounding pharmacies
are leary of this legislation. Reid Paul writes in Drug Topics, "The act
gives power to the FDA to inspect all retail pharmacies that make or
dispense compounded medications and to determine whether or not compounded
medications are medically necessary or are "essentially copies" of existing
FDA-approved medications. In addition, the act would take a number of steps
to inhibit the distribution of compounded medications beyond state lines. It
requires compounding pharmacies to provide detailed documentation on all
intrastate orders and asks state pharmacy boards to "discourage the
distribution of inordinate amounts of compound drug products in interstate
commerce."

The American Association for Health Freedom (www.healthfreedom.net ) has
posted the draft bill and other information at
http://www.healthfreedom.net/index.p...209&Itemid=244

The following weblinks also provide access to comments pertaining this
legislation:
http://a-champ.org/documents/FINALJo...SDCA3-7-07.pdf
http://www.consumersunion.org/pub/co...re/004384.html
http://www.aphanet.org/AM/Template.c...ContentID=7591
http://www.drugtopics.com/drugtopics....jsp?id=414436

The Senate Special Committee on Aging has called a hearing April 19 to
discuss bioidentical hormones. No doctors who uses bio-identical hormones
in their practice have as yet been invited to testify.

How You Can Get Involved:
(1) Call Your Senators (each of us has 2) and ask to speak to the
Legislative Assistant responsible for health issues. Tell your own personal
story about the importance of compounding products and ask for your Senators'
helping in preserving your access.
(2) Follow up with a letter to your Senators. (Faxing is better than
mailing.)
(3) Email the Senate Health, Education, Labor and Pensions Committee:
[email protected] or visit the American Association of Health
Freedom Website to send a letter via their portal.
http://www.healthfreedom.net/index.p...209&Itemid=244

The Senate HELP Committee Members are: Edward Kennedy (MA) (Chairman),
Christopher Dodd (CT), Tom Harkin (IA), Barbara A. Mikulski (MD), Jeff
Bingaman (NM), Patty Murray (WA), Jack Reed (RI), Hillary Rodham
Clinton(NY), Barack Obama (IL), Bernard Sanders (I) (VT), Sherrod Brown
(OH), Michael B. Enzi (WY) (Ranking Minority Member), Judd Gregg (NH), Lamar
Alexander (TN), Richard Burr (NC), Johnny Isakson (GA), Lisa Murkowski (AK),
Orrin G. Hatch (UT), Pat Roberts (KS), Wayne Allard (CO), Tom Coburn, M.D.
(OK).

The Senate Special Committee on Aging Members are: Herb Kohl, Chairman
(Wisconsin), Ron Wyden (Oregon), Blanche Lincoln (Arkansas), Evan Bayh
(Indiana), Thomas Carper (Delaware), Bill Nelson (Florida), Hillary Clinton
(New York), Ken Salazar (Colorado), Bob Casey (Pennsylvania), Claire
McCaskill (Missouri), Sheldon Whitehouse (Rhode Island), Gordon Smith,
Ranking Member (Oregon), Richard C. Shelby (Alabama), Susan Collins (Maine),
Mel Martinez (Florida), Larry E. Craig (Idaho), Elizabeth Dole (North
Carolina), Norm Coleman (Minnesota), David Vitter (Louisiana), Bob Corker
(Tennessee), Arlen Specter (Pennsylvania)

If you live in a state which is represented by a member of one or both of
these Committees, you have more leverage in gaining access to a member and
having your voice heard. There is concern that this language will be
slipped onto another bill, sidestepping a full markup and passage. Also,
remember there are at least three presidential candidates on these
committees (Clinton serves on both), so if you are a supporter of one of
these candidates for the White House, consider contacting their campaign and
state your opposition to this legislation.

B. Draft guidance for industry entitled ``Complementary and Alternative
Medicine Products and Their Regulation by the Food and Drug Administration
Docket No. 2006D-0480 On February 27, 2007, through the Federal Register,
the FDA announced the availability of this draft guidance document.
Comments are due to the agency by April 30. While requests have been
submitted to the agency to extend the deadline, that extension has not yet
been granted. Therefore, everyone involved as a consumer, marketer, or
professional involved in the CAM field needs to take action in the next two
weeks regarding this guidance. The FDA staff stated that they decided to
draft this guidance after reading an article which apparently stated the FDA
did not regulate homeopathy (a mistatement). An internal document was
drafted and completed in December 2006, but not released until the end of
February: http://www.fdagov/OHRMS/DOCKETS/98fr/E7-3259.htm (While it was
reviewed by the Department's Counsel, it was NOT reviewed by the White House
Office of Management and Budget, which announced that all agency guidance
documents would soon require their approval.)

The document is posted at
http://www.fda.gov/OHRMS/DOCKETS/98f...80-gld0001.pdf The entire
document is troublesome in part due to the very subjective way it is written
(using word like might rather than shall or will). Two examples of
troubling issues include:

Probiotics might be regulated as biologics (the same category as vaccines).
'Functional foods" that are recommended to treat disease could be regulated
as drugs.

It would appear from this document that if a doctor or other health care
professional or printed material suggests the use of any product (food,
homoepathic product, and dietary supplement) should be consumed or used to
prevent, mitigate or treat disease, the product may be regulated by the FDA
as a drug. Dietary Supplement manufacturers are well aware of their
existing constraints in marketing their products, however; the FDA's
guidance document does not specifically clarify that the free speech of the
media and health professionals will be protected and excluded from their
regulatory considerations. In essence, even the governent's recommendations
to eat fruits, vegetables, and whole grains to prevent cancer, heart
disease, etc. may place these products into the 'drug' category.

How You Can Get Involved:
(1) Submit your comments to the FDA docket.
(2) Send a copy of your comments to your own legislators (we each have one
Representative and two Senators. You can do this online so that your
comments will be publicly available through www.congress.org or to find out
how to contact your own legislators, visit www.senate.gov and
www.house.gov).

Comments to the docket can be submitted three ways, mail, fax, or email:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, MD, 20852
E-Mail: [email protected]
Fax: [phone]

Words of caution: First, do not put personal information such as social
security number, home phone, or other privacy information in the
correspondence as it will be posted on the web. Second, a submission to the
FDA docket (and to the Congress) need to be completely factual (as if you
were under oath) - I bring this up because the owner of a dietary supplement
company submitted comments to an FDA docket several years ago that appeared
to be inaccurate and an attempt was made to prosecute him for lying to the
government. Make sure you include the docket number on the correspondence.

Please get the word out and get involved.

******
Below is my letter to Senator Clinton:

April 23, 2007

Senator Hillary Rodham Clinton
476 Russell Senate Office Building
Washington, D.C. 20510

Re: "Complementary and Alternative Medicine Products and Their Regulation
by
The Food and Drug Administration
Docket No. 2006D-0480

Dear Senator Clinton:

I am writing you to express my grave concerns over the above mentioned FDA
draft guidance document relating to regulation of Alternative Medical
practices and products. Unfortunately, I recently learned that as of April
30, 2007, no further comments about the proposals will be accepted.

I am a conventionally trained physician, a graduate of Brown University,
postgraduate premedical work at Columbia, MD from Cornell University Medical
College. I completed a specialty fellowship in cancer immunology under the
late Dr. Robert A. Good, at the time the most published author in medicine
and considered the "Father of Modern Immunology." While working under Dr.
Good, I began investigating nutritional approaches to advanced cancer.

I currently use scientifically sound nutritional approaches in my practice
and have published in the peer review literature myself. Though my therapy
is considered by some "alternative", my research has been funded extensively
by Procter & Gamble and by Nestle, both very mainstream corporations.
Columbia University here in Manhattan received a $1.4 million grant from the
National Center for Complementary and Alternative Medicine to pursue a
National Cancer Institute supervised study evaluating my therapeutic
approach in patients diagnosed with advanced pancreatic cancer, with FDA
Investigational New Drug (IND) approval. In 2000, I spoke as an invited
presenter at a Washington, D.C. hearing of President Clinton's "Presidential
Commission on Complementary and Alternative Medicine."

I was featured in a lengthy profile appearing in the February 5, 2001 issue
of The New Yorker Magazine, which discussed the origins of my research, and
my goal to have my work appropriately studied under rigorous academic
supervision. As the article makes clear, though my therapy is nutritional
in nature, I have always believed in appropriate scientific methodology.

Many alternative therapies, such as my own, originally developed outside the
academic mainstream, which is dominated by drug company thinking and drug
company funding. Nutritional substances cannot in general be patented under
current regulations, so little financial incentive exists for industry
investment. Yet many of these therapies, like my own, are nonetheless
promising and deserve support, not suppression.

Recently, the FDA presented the above referenced draft guidance document.
While we should all be deeply concerned about reckless or unsubstantiated
claims for any substance, be it drug or nutritional in nature, I am troubled
that the FDA proposals regarding Alternative Medicine Practices and Products
seem overly broad and potentially draconian in nature. These guidelines, if
enacted, seem to say that anyone, including a physician, who recommends any
dietary or nutritional substance that has not gone through the FDA drug
approval pipeline, even if relying on sound scientific evidence, could be
potentially criminally prosecuted for making unapproved drug claims. For
example, I might be forbidden from prescribing as part of my treatment plan
whole grains or carrot juice, despite the weight of scientific evidence
confirming benefit, because neither whole grains nor carrot juice have been
FDA approved as drugs.

I cannot believe that it is in the best interest of the American public, or
American Medicine, or particularly, the health of the American people, to
criminalize scientifically valid nutritional recommendations. The FDA
guidelines are over-reaching, potentially unconstitutional, encroaching on
state's rights, and not in the best interest of the American public.

I know how deeply you care about health issues, health care and the health
of all Americans. Please, I hope you or your staff could contact the FDA,
discuss their proposal, and request that they withdraw these excessive and
unneeded recommendations. Physicians, and the American public, need free
access to nutritional information, and should have the freedom to act based
on the scientific evidence, even if the substances or foods in question have
not passed through the FDA drug approval apparatus.

Thank you for your help in this matter. I would of course be happy to
discuss this issue with any of your staff members.

Sincerely,

Nicholas J. Gonzalez, M.D.

*******
Below is my letter to the FDA:

April 23, 2007

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852

Re: Docket No. 2006D-0480
"Complementary and Alternative Medicine Products and Their Regulation by the
Food and Drug Administration"

To Whom it May Concern:

I am writing to offer my comments regarding the above referenced draft
guidance document. I am a conventionally trained physician, a graduate of
Brown University, postgraduate premedical work at Columbia University, MD
from Cornell University Medical College, fellowship training in cancer
immunology under the late Dr. Robert A. Good, considered by many to be the
"Father of Modern Immunology." While pursuing my academic training, I began
investigating the relationship of certain nutritional substances to cancer
and other degenerative diseases. I currently use nutritional approaches in
my practice based on the scientific literature, and have published in the
peer review literature myself. My work has been funded by Procter & Gamble
and by Nestle, both very mainstream corporations, as well as by NCCAM for a
clinical study with FDA IND approval. I have always believed in appropriate
scientific methodology, regardless of the nature of the treatment in
question.

While we should all be deeply concerned about reckless or unsubstantiated
claims for any substance, be it drug or nutritional in nature, I am troubled
that the FDA proposals regarding Alternative Medicine Products seems overly
broad and potentially draconian in nature. The FDA guidelines, if enacted,
seem to say that anyone, including a physician, who recommends any dietary
or nutritional substance that has not gone through the FDA drug approval
pipeline, even if relying on sound scientific evidence, might be criminally
guilty for making unapproved drug claims. I believe I would be forbidden
from prescribing as part of my treatment plan whole grains or carrot juice,
despite the weight of scientific evidence confirming benefit, because
neither whole grains nor carrot juice have been FDA approved as drugs.

I cannot believe that it is in the best interest of the American public, or
American Medicine, or particularly, the health of the American people, to
criminalize scientifically valid nutritional recommendations. The FDA's
guidelines are over-reaching, potentially unconstitutional, encroaching on
state's rights, and are not in the best interest of the American public.

Please, withdraw your recommendations. Physicians, and the American public,
need free access to nutritional information, and should have the freedom to
act based on the scientific evidence, even if the substances or foods in
question have not passed through the FDA drug approval apparatus.

Thank you for the opportunity to express my comments.

Sincerely,

Nicholas J. Gonzalez, M.D.

[NMDemDist2]

1. done, K&N big pharma has enough power as it is n/t

[benEzra]

2. K&R. (n/t)

[otohara]

3. Thanks For Reminder