MATT LAUER, co-host:
This morning on
TODAY'S HEALTH
, a gene controversy. Private research firms hold the patents to nearly 20 percent of human
genes
, but a lawsuit filed on Tuesday by the
ACLU
challenges one such
patent
. It was granted to a company to study two
genes
associated with breast and ovarian cancers.
NBC
's chief medical editor, Dr.
Nancy Snyderman
, has details.
Dr. NANCY SNYDERMAN reporting:
May 13th
,
2008
, one year ago today. The day that
Elizabeth Suriani
's life changed forever. She was diagnosed with
breast cancer
.
Ms. ELIZABETH SURIANI:
I remember the exact day. I excused myself because my daughter was here and went upstairs and closed myself in the closet and cried.
SNYDERMAN:
Elizabeth
opted to have a double mastectomy, chemotherapy and radiation in the hopes of conquering the disease. But her fight was just beginning.
Ms. SURIANI:
I didn't know that because I ended up with this aggressive type of
breast cancer
at an early age that it could mean that I have a significantly increased risk of
ovarian cancer
. And the only way to determine that is through this
genetic test
.
SNYDERMAN:
The
BRAC
analysis test. A simple
blood test
that can determine if a person has an altered gene. If a woman has this genetic mutation, her likelihood of developing
breast cancer
is up to 87 percent. Her risk of getting
ovarian cancer
, about 50 percent. The
US Patent Office
granted
Myriad Genetics
the
exclusive rights
to study the
BRCA
genes
. They are the only company that can offer this test. A full screening can cost more than $3,000 and they don't accept all types of insurance. Like in
Elizabeth
's case, a
single mom
who works part-time from home to better care for her eight-year-old daughter.
Ms. SURIANI:
I made the choice to spend more time with my daughter while she was young, but it would be a tragic irony if my time with her is shortened because I didn't make as much money during that time in order to pay for a test out of my pocket.
SNYDERMAN:
In addition to the expense, some argue that the company's patents deny patients an important second opinion.
Dr. WENDY CHUNG (Columbia University Medical Center):
Without competition within the field, there is not the incentive to either drive down the cost of testing or improve the product by offering a test that's able to be more sensitive and detect more of the disease.
SNYDERMAN:
Researchers also say that these patents limit their ability to develop new treatments. Now, the
ACLU
is stepping in. On Tuesday, they filed a lawsuit against the
US Patent Office
and
Myriad
.
Mr. CHRIS HANSEN (Senior Staff Attorney, ACLU):
Myriad
has the authority under
patent law
to say `It's my gene, it's not your gene and I get to decide whether you look at it, I get to decide whether you think about its consequences, I get to decide whether you do research on it.' In our view, that's unacceptable.
SNYDERMAN:
Myriad
tests more than 500 samples a day and says that insurance covers the cost for three-quarters of its patients, and they maintain that without the sole right to work on these
genes
, they, nor any or other company, would make the investment needed
in the first place
. But that's little consolation to
Elizabeth
who worries not only about her own health but what she could be passing on to her daughter.
Ms. SURIANI:
The fact that there's a
patent
on the gene itself, not on the test, not on the process, but on the actual gene, it's just mind-boggling.
SNYDERMAN:
And we should mention,
Matt
, that we reached out to not only the
US Patent Office
but also
Myriad Genetics
and
Myriad Genetics
said they have no comment. We're
still
waiting for a reply, hoping that one of them will give us an answer.
LAUER:
Let's just go a little further here. So this company,
Myriad
, has this
patent
on these two
genes
, right?
SNYDERMAN:
Correct.
LAUER:
Not because they discovered the gene...
SNYDERMAN:
And not just the test...
LAUER:
Right.
SNYDERMAN:
...but the
genes
themselves.
LAUER:
But not because they discovered the
genes
, it's because they're the first ones to say, `Hey, we'd like a
patent
on it.' I understand why they would want the
patent
, but why would the
government grant
it?
SNYDERMAN:
Well, they will argue that they did more than find just the
genes
. They purified the
DNA
from the
genes
which allowed the test, because normally you can't get a
patent
on this type of thing, you know, just biology. But nonetheless, 20 percent of the
human genome
is now patented, but other companies like the gene for cystic fibrosis have been shared with other researchers and other laboratories.
LAUER:
Right.
SNYDERMAN:
Myriad
is saying, `
Uh
-uh, we put the
patent
in, we own the information, we are going to take it one step further and we, therefore, invested in it.'
LAUER:
Throughout business throughout our lives,
profit
motive is important. It's what gets these companies you just mentioned to invest money in studying the
genes
and developing the tests and things like that. How does the medical community view this though?
SNYDERMAN:
I think we've heard a lot of
silence
in the last
24 hours
because this is in some ways the backbone of biotech. You find these things, you put significant capital into it, and then you build a business around it. A lot of university professors, people in the
private sector
, patient advocates are saying, `
Wait a minute
. What you're basically telling me is beyond the
genes
, you're trying to have a
patent
on knowledge. And if I don't have competition, I can't drive to a cheaper test, a faster test.'
And I
would argue one thing. We always know that no test is foolproof. What if
Myriad
has a
false positive
or a
false negative
?
LAUER:
Right. There's no second opinion here because no one else can test the gene.
SNYDERMAN:
There's no second opinion. Right, and that's where I think a big concern is. Now it also argue that because we know there's such a vibrant community around
breast cancer
, if this happened to be another disease, would we be seeing this kind of ramped-up interest and would the
ACLU
be stepping in? I'm not sure we know the answer to that.
LAUER:
All right, it's interesting.
SNYDERMAN:
But here's one thing I am going to predict. This is on its way to the
Supreme Court
. I don't think this is going to be the end of it. Can you own someone's
genes
? Can you own the knowledge? Can you stifle
scientific investigation
around it? I would follow this to the
Supreme Court
.
LAUER:
We'll follow it with you,
Nancy
.
SNYDERMAN:
Thank you,
Matt.
“ ”