From: Nancy Wexler

To: JMSharf1@fda.hhs.gov
Date: 5/16/2010 6:21 PM
Subject: Re: thank you

Dear Peggy and Josh,

I cannot thank you enough for saving the situation at almost the 12th hour!!!!!!!!!!!!!!
These companies MUST BE REGULATED BY THE FDA - AT A MINIMUM!!!

Many thanks again for responding to the crisis so quickly and efficiently – especially
when there are so many other pressing matters on your agenda.

Many thanks again!!

Yours,

Nancy

Nancy S. Wexler, Ph.D.

Higgins Professor of Neuropsychology
Columbia University
1051 Riverside Drive, Unit 6, PI Annex 371
New York, NY 10032
212.543.5667, fax 212.543.6002
wexlern@pi.cpmc.columbia.edu

President, Hereditary Disease Foundation

212.928.2121, fax 212.928.2172
www.hdfoundation.org

>>> "Sharfstein, JM" <JMSharf1@fda.hhs.gov> 05/16/10 12:11 PM >>>

Dear Dr. Wexler,

Thank you for the email message-You may have seen that FDA was in touch with
pathway genomics and Walgreens is not moving forward with selling the products at this
time. I appreciate hearing your concern on this issue, and we'll keep you posted of
further updates.

Take care,
Josh

Joshua M. Sharfstein, M.D.

Principal Deputy Commissioner
From: Nancy Wexler
To: Joshua Sharfstein; Peggy Hamburg
Date: 5/11/2010 5:24 PM
Subject: DNA Testing Kits

Dear Peggy and Josh,

I read Rob Stein=s story in today=s Washington Post

(http://www.washingtonpost.com/wp-dyn/content/article/2010/05/10/AR2010051004904.
html) regarding the marketing plan announced today by Pathway Genomics of San Diego
to sell its Insight test at 6,000 of 7,500 Walgreens stores.

My close look at the company=s website makes me even more alarmed about what they
are proposing. There is an extremely long list of diseases for which they claim that their
analysis of risk methodology can be predictive and thus, possibly preventive.

Just to give an example of some of the problems:

1) Even homozygous ApoE 4 is not predictive for an increased risk for Alzheimer=s
disease.
2) They are unable to provide testing for any of the BRCA1 or BRCA2 genes because
of Myriad=s patents. They also did not include men who also have a risk for breast
cancer. Since they do not include the major risk factors for breast cancer, their data will
be very misleading.
3) They claim to do a test for a sporadic risk for ALS. They are not testing for the
genetic form – which is definitely predictive. Perhaps they do not test for SOD1 because
the information would be much more devastating. But would the “sporadic form” be any
better news?
4) They claim they can do genetic testing for diabetes 1 and 2 and that is hardly
predictive.
5) The myriad of genes which contribute to Parkinson=s disease is confusing to even
the most sophisticated geneticists and neurologists. It is unclear what information will be
provided in this test.

There are multiple issues involved in the approach of Pathway Genomics Personal DNA
Insight Test:

1) They consider the genetic information and genetic counseling results as if they do
not need to be approved by any oversight organization. But we all know that there is
tremendous amount of variability in the genetic counseling which is provided – even in
the best institutions.
2) They are unclear about what SNP data will be used and its ability to be predictive.
3) They permit adults to test their children, without the children=s permission, as long
as they follow the ASHG testing guidelines which say the test needs to be done for the
benefit of the child. Who makes this determination? The family? The lab?
4) They assume that because they have CLIA-approved laboratories to do the DNA
testing that this is sufficient for FDA approval. Many Ahome-brew laboratory@
approaches are potentially pushed into the public by being teamed up with a
CLIA-approved laboratory. Even though the laboratory has the minimum standards, this
does not mean that there is rigorous control of the test or the people providing feedback.
5) We all know the devastating impact of too little or too much information in the
wrong hands at the wrong time. There is nothing in their procedures that deals with how
they are going to provide the information, how it is described, what kind of counseling
and follow-up will be provided and how to interpret results which will be given. We all
know that many people do not understand the complexity of genetic risk.
6) The premise of the test is that doctors are not on the side of patients and are unable
to order or interpret diagnostic tests when relevant to the patient. It is a marketing
approach that speaks to people=s Aright to know@ that is a veiled attack on the
physicians who should be or could be ordering these tests if they wanted them.

Pathways Genomics is just the latest in a scheme of companies who have benefitted from
the Human Genome Project. Unfortunately, many pharmaceutical and biotech companies
are guided by avarice B however they may cloak their entrepreneurial spirit in a premise
of self-understanding and self-awareness. Pathway Genomics, 23andMe, deCODE and
Navigenics are not organized to advance humanity, but to take advantage of knowledge
that is in the public domain. The Human Genome Project, the NIH and other countries
generously shared this information. Since they are advertising for their companies things
that will keep your DNA securely, this inflames people=s paranoia that they will lose
their health insurance if these genetics risks become known.

I do not know how these companies manage to evade the careful and thoughtful purview
of the FDA. It is only through the decision-making of the FDA to step in and look at all
of the component parts of the test B the laboratory=s performance, as well as test
information, feedback, counseling, follow-up and response B that we can understand
better what is being proposed and sold. I think the FDA needs to step in and do these
things. Without your strict and forceful response to review carefully all components of
such complicated pieces of work, I fear nothing but trouble ahead. There will be a prize
for who can get out the most kits.

It would be problematic, after all of these decades of struggle to complete the Human
Genome Project, putting billions of dollars of public money throughout the world,
struggling to make genotype costs go down and continuing to put all of this information
into the public domain freely available, to have the people for whom the Human Genome
Project was done suffer from misinformation and exploitation.

I hope you can call a moratorium on putting out those devices and pulling the ones that
are already there. I hope you can review all aspects of such a charged endeavor. And I
hope you will realize that only through the very careful thoughtfulness and purview of the
FDA, that safety and efficacy can be assured. Only through careful scrutiny and licensing
of these devices can we hope to improve the health and well-being of the population at
large.

Yours,
Nancy