Risk Management: Breast Cancer, Business and Patents

The
backdrop to the third event in the Progress Educational Trust's (PET) 'Breast Cancer: Chances, Choices
and Genetics' series was the Myriad Genetics gene patenting legal saga,
which came to a conclusion last year with Myriad being denied a patent on
the isolated forms of the BRCA genes (see BioNews 709).

For those with a taste for such things, the case
was particularly engrossing as it reified so many current debates in science: the
role of the profit motive in rewarding innovation; the ethics of claiming universal,
naturally-occurring products as private property, and all the myriad (sorry!)
knock-on effects for privacy, insurance and intellectual property (IP). No wonder
it has sparked such debate.

This discussion was organised
around three main topics laid out by chair Professor Graeme Laurie: the
truths and myths of the biotech and pharmaceutical industry's impact on cancer research and care,
the role that patenting plays, and finally the wider implications of commercial
interest in genetics and large-scale datasets.

Four speakers, from diverse
backgrounds, offered opinion and expert advice on these topics. As is the norm
for PET events, each was given a few minutes to present their view before questions,
discussion and debate with an eager audience.

Dr Angela Kukula, director of
enterprise at the Institute of Cancer Research (ICR), explained her organisation's
viewpoint on collaboration with industry. The added capital and facilities of industry
allow them to take research further towards the eventual development of
products, and so is mutually beneficial, she said.

The ICR's policy on patents
is not uniform. In some cases, such as in drug discovery, their position is
that patenting encourages investment via the opportunity of exclusivity. Other
discoveries such as biomarkers are not patented to allow as much freedom of
access as possible. Intriguingly, Dr Kukula said that there are occasions when the
ICR will patent genes, in order to prevent others from doing so, again in an
attempt to allow freedom of access.

Alexander Denoon is a partner at
a law firm working in the life sciences sector. He continued on the topic of IP and patenting and is clearly a firm believer in providing
adequate rewards to promote innovation in the life sciences. He introduced the
concept of 'regulatory IP' by which regulation could offer rewards such as temporary
monopoly in areas like drug development for a rare disease.

The third speaker was Dr Ian Cox,
a former GP who now works in insurance and sits on the genetics panel at the
Association of British Insurers (ABI). His presentation was short, giving a
welcome explanation of the workings of critical illness insurance and his role
in the ABI.

The final presentation was from Jenny
Dunlop, a counsellor specialising in fertility, who had breast cancer herself ten
years ago. She brought a personal perspective to the debate. She was
particularly concerned about potential exploitation of vulnerable and sometimes
desperate patients with untested treatments and the excesses of
commercialisation.

The ensuing Q&A focused heavily on Dr Cox, who explained insurers'
policies and his opinions openly and sincerely. In the UK there is a moratorium
that prevents predictive genetic testing being used by insurance companies in
calculating premiums. Dr Cox was in favour of this, as he believes that the flexibility
that comes from working under a moratorium works well within a rapidly changing
field.

The discussion was lively and
informative, and moved to broad questions on large genetic data sets and
regulation. Denoon spoke in favour of openness, as it is this that drives the
innovation of treatments and therapies. He was of the opinion that there is a
public paranoia about disclosing genetic information that is an inhibition to
this.

For myself, I felt 'paranoia' was
a bit strong. Not unreasonably, genetics is perceived as being particularly personal; third-party disclosure is therefore a highly sensitive subject.

There seemed to be consensus
among the audience and panellists on the lack of public understanding of the insurance
and biotech industries' involvement in cancer and genetics, resulting in a
widespread suspicion of their motives.

Dr Cox explained that large data
sets are used by insurance companies so they can understand current trends in
cancer incidence and survival and therefore set their premiums based upon the evidence.
It was a persuasive argument; it seems unlikely that a company would have
reason to attempt to personally identify individuals from genetic data as is
sometimes feared.

The sharing of genetic
information to approved researchers and companies is one of the proposed
features of the NHS's care.data project. Each panel member was asked under
what conditions they would be willing to share their own genetic profile. A
commonly voiced requirement was for anonymisation.

However, as Professor Laurie
pointed out, complete, guaranteed anonymisation is unlikely to be possible. Here,
I felt myself siding with Denoon; the potential benefits of large-scale
sharing of genetic data should outweigh concerns of personal identification.

The idea of private companies
making obscene profits from others' misfortune is frequently raised in opposition
to commercialisation in cancer and healthcare and Dunlop voiced such concerns
here. She also suggested that greater
transparency on where pharmaceutical companies' money was reinvested would be welcome.
Denoon countered that publicly traded pharmaceutical companies already provide
this but it is not widely read and that profits are rarely large enough to be
considered obscene.

This was a highly informative event, with many
important points on industry's involvement with cancer and genetics covered.
Although I did feel that the scope of the evening might have been slightly too
broad, the quality of discussion was excellent and prompted me to examine my
own opinions.

As genetic testing becomes more widespread it is vital that we
examine the way in which we commercialise and regulate new technologies and
consider the knock-ons into areas like insurance. Events like this are an
excellent way to do just that.

Have your say about breast cancer and genetic testing, by taking a minute to complete the Breast Cancer Poll on BioNews here.