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BRCA-gene patents/ Conflicts of interest



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With best regards
Florianne Koechlin


Gene tests - the El Dorado of genetic engineering?
The example of Myriad Genetics and the patented BRCA1 gene

('Conflicts of interest', Basel, 20 and 21 February 2003
Florianne Koechlin, www.blueridge-institute.ch)

I'm a white, European woman, a native of this beautiful city of Basel. I
have a pretty high risk of getting breast cancer. It is five times higher
than it is for an Asian woman from rural parts of Asia. But when this woman
migrates to Europe, to Basel, her risk factor tips up to my risk factor
within one or two generations. So it must be something in the environment
or in the way we're living here that enhances breast cancer incidence.
A Swedish study by the Karolinska Institute looked at the records of 90,000
twins, identical and non-identical ones, and their differences in getting
breast cancer. They found that environmental effects are much more
important in triggering breast cancer than genes. They conclude that cancer
is not hardwired in the genes. They ask why researchers are not spending
more funds on identifying avoidable risk factors of cancer instead of
putting all their energies into genetics (Lichtenstein et al.)
In the meantime more extensive meta-studies underline this fact: around 5 %
of all breast cancer diseases have a family history of the disease, 95 % do
not.
As for the genetic side: researchers at the US firm Myriad Genetics decoded
two so-called human breast cancer genes, BRCA1 and BRCA2. (To talk of
'breast cancer genes' is wrong. It's at most a gene mutation, which may
enhance the risk of women getting breast cancer.) Researchers at Myriad
developed gene tests with these gene sequences.
Now: what happens when a woman gets a positive test result for the BRCA1
gene? She has a 50 to 70% chance of getting breast cancer up until the age
of 70. But how can she interpret this probability? Up to now, there are no
preventive actions apart from those a woman here in Switzerland is told to
take: to examine her breasts after each period and to go to the
gynaecologist once a year. The risk-lowering effect of a mastectomy as a
prevention is not scientifically proven. The same goes for Tamoxifen and
chemotherapy as preventive measures. So what does this positive result mean
for her own life, for her quality of life, for her lost hopes and for her
fears? A healthy person who is not yet sick but knows that she has a higher
likelihood of being so in the future - this is a difficult situation to
deal with.
The other interesting factor is that 30 to 50% of all women with a positive
test do NOT get breast cancer. Why not? Apparently there are other genes,
other factors, other pathways playing a role; it's not a totally determined
story, even with a mutation of the genes BRCA1 or -2.
Lets go back to the fact that 95% of all breast cancers do not have
hereditary causes. Looking at this figure, I would na´vely think that 95%
of all research funds, of all brain-power would focus on finding
correlations between environment, nutrition or life-style which cause or
are involved with 95% of all breast cancers. This research would focus, for
example, on pseudo-oestrogens in the environment, or on nutrition. And I
would assume that only 5% of all research funds would go into genetics. But
we all know that it's the other way around: although I do not know the
exact figures, it's obvious that research is focusing on genetics, on
so-called breast cancer genes, on further genetic causes, on further gene
tests .
Patents on the BRCA1 gene
This hype over genes may have many causes. One main reason, and this is the
hypothesis I want to talk about, is economic interests and patents. I'll do
this by taking one example: the so-called breast cancer genes and the US
firm Myriad Genetics.
Myriad Genetics applied pretty swiftly for patents on these genes. In the
US they have patents on both BRCA1 and BRCA2 genes. In Europe they have
three patents on the BRCA1 gene and one patent for the BRCA2-gene, from the
European Patent Office in Munich (EPO).
The last European patent on the BRCA1-gene, with the number EP 0705902, was
extremely broad. I know it well, because I draw up an opposition to this
patent on behalf of the Social Democrats of Switzerland.
This patent includes among other things:
▀ different variations of the gene sequence BRCA1
▀ the BRCA1 gene of the wild-type. This means the normal, non-mutated gene
which most of us women have.
▀ all diagnostic and therapeutic applications of these genes
▀ all vaccines derived 'with the help of this gene'
▀ all animals which incorporate one of the gene sequences described
▀ all future applications of these gene sequences, be it for tests,
therapies or vaccines, which are not yet known. There was a note lately
that BRCA mutations are also connected to pancreatic cancer - so Myriad
also has a monopoly control over this research area and market, even though
nobody knew about these correlations at the time of the patent application
▀ all proteins derived from these genes, and all their applications, known
or not yet known.
As patent-owner you can ask for license fees or cross-licenses; this is
what most patent-owners have done up to now. But you also have the right to
exclude others completely from your patent invention. Myriad Genetics is
aggressively trying to make use of the exclusion right granted by the
patent. They want to be the only group, world-wide, to make use of this
patent and to develop gene tests. The firm even forbids all other labs,
institutes or firms to carry out the tests. Probes for a gene test have to
be sent from all over the world to Myriad's Institute in Salt Lake City. In
the US, Myriad Genetics successfully denied all other labs the right to
develop similar tests, because of the patents they hold. The costs of the
tests went up immensely. In some countries the costs for a test doubled. As
a consequence, the Canadian 'Hereditary Cancer Program' in British Columbia
cancelled all in-house testing.
In Europe, the Curie Institute in Paris, which also offers gene tests on
BRCA1, was one of the many who filed opposition to one of the BRCA1 gene
patents. The Curie Institute argues that Myriad's procedure hinders
independent research. It has gene tests cheaper than Myriad's, apparently
better suited for BRCA1 gene mutations prevalent in Europe. But the Curie
Institute is afraid it will be forced to abandon these tests because of the
Myriad patents.
Another point is that Myriad is aggressively campaigning for their gene
tests in the States. They started to broadcast TV ads in Atlanta and
Denver. The advert showed an attractive woman telling the viewer, 'Breast
cancer runs in my family. I wondered if it would be inevitable. I found it
didn't have to be.' A small note indicates that a doctor's approval is
needed. But persistent patients should get a doctor's permission without
problems. Apart from being a lie - there is no preventive breast cancer
cure, as the ad is suggesting - this campaign illustrates plainly that
careful counselling programs, or national control programmes are 'devout
wishes', as we say in German. Together with internet ordering they're
making a nonsense of all these trials to carefully control and accompany
gene test programmes.
Not only Myriad Genetics
I often hear from proponents, 'OK, Myriad is exaggerating, we all know
that, and breast cancer is a special case,' etc. But I do not agree.
First, there seems to be huge economic potential, a multibillion market on
gene tests in the area of genetic engineering and genomics, an area where
there have been many promises and few achievements up to now, and where
shareholder values are therefore in rather bad shape. So gene tests seem to
be the El Dorado of genetic engineering and genomics. And gene tests can be
patented, because human genes can be patented.
Second, other firms are already following in Myriad's footsteps and are
using their patents to exclude other researchers and institutes from
entering their area. This is bad news for research and for public health:
if diagnostics and treatment of a common disease are monopolised by one
single multinational firm, this firm dictates all the conditions - a
dangerous development.
Third, patents on genes grant an exclusive and broad monopoly control. The
first one to get there takes it all. You stake out your claims in a vast
research area, and it's blocked for all others. This might also explain the
aggressiveness and hasty and fierce competition in this research area: you
have to be first or the market will punish you.
Fourth, it seems obvious to me that patents are increasingly directing
research: only research projects with the prospect of lucrative patents
will be financed. So breast cancer research on genes, with the prospect of
acquiring a gene patent, will be financed; breast cancer research on
environmental interactions will not, because you can not patent
environmental interactions.
This point seems especially problematic. Just a few weeks ago there was a
congress in Bonn on genomics, 'Bonn Genomics 2003', with many experts in
this field. The overall impression was, according to the press, that of a
'loss of orientation'. The gigantic expenditure of research into genomics
is barely rewarded. The results up to now have been disappointing. To view
diseases mainly from a genetic perspective seems to be a cul-de-sac. The
links claimed between genes and diseases are overstated. It's obvious that
many common diseases, and also many cancers, are too complex for simple
gene tests; they are caused by hundreds of genes, together with hundreds or
thousands of gene products and other molecules, together with
psychological, social and environmental factors. And many cancer experts
say today that looking more closely at carcinogenic substances could bring
us farther ahead.

References:
Bochar D., Cell, 2000, 102, 257
Ford D. et al, The Lancet, 1994, 343, 692
Lichtenstein P. et al., 2000, "Environmental and Heritable Factors in the
Causation of Cancer - Analyses of Cohorts of Twins from Sweden, Denmark,
and Finland", NEJM, 343 (2), 78
Merz J.F. et al, 2002, 'Diagnostic testing fails the test', Nature, 415, 577
Nuffield Council on Bioethics, UK, 'The ethics of patenting DNA', ISBN 1
904384 021, July 2002
Pagan Westphal, S., 'The people vs patents, 2002, New Scientist, 13.7.2002
Thomas, S. 'Their hands on your genes', New Scientist, 3.8.2002
Williamson, AR , 'Gene patents: Socially acceptable monopolies or an
unnecessary hindrance of research?', 21.9.2001 (news.bmn.com/hmsbeagle)

Literature:
on www.blueridge-institute.ch (topics//'no patents on life'):
*Treaty Initiative to Share the genetic commons
*Vernehmlassung zum Entwurf des Bundesgesetzes Řber Erfindungspatente
(Florianne Koechlin)
* mail-out 'No patents on life'
Florianne Koechlin 'Das patentierte Leben', 1998, Rotpunktverlag
Opposition to patent EP 0 705 902, opponent: SP Schweiz, 14.8.2002
(www.european-patent-office.org)


Florianne Koechlin
Blueridge-Institute
Blauenstrasse 15
CH 4142 MŘnchenstein

http://www.blauen-institut.ch
http://www.blueridge-institute.ch