DNA is the molecule that is the hereditary material in all living cells.
Genes are made of DNA, and so is the genome itself. A gene consists of enough DNA to code for one protein, and a genome is simply the sum total of an organism’s DNA.
DNA is part of our bodies. Medical staff/researchers have to have our blood, our skin, a strand of our hair or some other part of our body to “see” the DNA.
“Canada is one of the only jurisdictions in the Western world that still allows gene patenting”. “Last year, the U.S. Supreme Court ruled that genes can no longer be patented.” (2) CHEO (Children’s Hospital of Eastern Ontario) is going to court to try to have some gene patents struck down. In this case, the patents are for “genes associated with a heart condition called long QT syndrome”. “The patents being challenged by CHEO are held by the University of Utah but were filed in Canada.” (2) They hope that this will set a precedent that will have all other genetic patents struck down. I hope they are successful.
“The U.S. and Europe have developed gene patent policies outlining what types of genetic information can be patented”. The European Union states that: ‘The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions,’” (6). In other words, you can’t patent a tree, or its root, because you discovered it. You did not invent it.
“Biotech companies want to patent genes so they can profit from testing of those genes.” Even “when patents are struck down….a company can still market tests but cannot do so exclusively, so the price drops significantly”. (2) It is, as usual, a case of follow the money.
But, CHEO is a “leader in genetic research”. They want your genetic information to be available to researchers and clinicians. They believe that “restricting access to genetic information by researchers and clinicians undermines patient care and is morally and legally untenable”. Alex Munter, CEO of CHEO said that striking down the law will “open the door to an era of personalized medicine,” where treatments are tailored to specific genetic characteristics. “Dr. Gail Graham, chief of genetics at CHEO”, said researchers at the hospital have not and will not patent any genes they discover”. (2) My question is: do they ask the patient for permission to use their genes for research, to keep those genes in their DNA warehouse, to share that DNA? Is this a case of genuinely caring about the rights of the patient? Or, is this a case of two rival gangs fighting over turf, that turf being our bodies, our information? Will our information just go to different researchers, without our real consent? It is even more concerning when you get into personalized medicine tailored to specific genetic characteristics. I find it “morally and legally untenable” that researchers, clinicians, etc. can take and use our medical information/body parts without our REAL consent. (2) There is a dark side to how this information can be used so we need to know if and how that can be prevented. Again we need transparency and accountability, which is not happening.
Problems with Patenting DNA:
A patent gives a company ownership of a particular area of the human genome. (3):
(a) “Lawyer Rebecca Gilsenan says there are many dangers to having a monopoly on this patent.
‘There’s a philosophical and ethical issue about commercializing the human body and its genetic material,’ she said.” (5)
(b) “When a lab does a panel that features information on larger parts of the genome – that information cannot be communicated to patients, again because of the patent. ‘We simply cannot accept a situation where a patent prevents us from diagnosing and treating a sick child,” Dr. Graham said.” (2) I think this means that if they accidentally discover that you have an illness, they can’t tell you about it unless they pay the patent company to test for the illness.
(c) If a person needs a genetic test, for example, for heart related problems, it must go the U.S., even if a Canadian lab is capable of doing the test. This increases cost, and reduces the number of genetic tests and possibly puts people’s lives at risk. (6) And once our information gets into the U.S. we have no control over it. Then again, we, the people, have no control over our own personal information in Canada.
So far, tests for BRCA1 and BRCA2 (breast cancer genetic mutations) are being conducted in Canada and the patent holder has not taken action. But that is not the case with all genetic patents. (2)
(c) If a person is tested for the breast cancer genetic mutations by Myriad Genetics, the person cannot get a second opinion because Myriad Genetics does not allow second opinions. (5)
(d) Other companies are not allowed to develop other tests, that may be better and cheaper because that would infringe on patents. (5)
(e) Myriad Genetics (a U.S. company), working with Canadian researchers at Sick Children’s Hospital and McGill and Laval universities (publicly funded institutions), discovered “BRCA1 and BRCA2 human breast cancer susceptibility genes”, from some people’s DNA. They patented the genes and created a test to identify these genes. So, where did they get the DNA? Does a U.S. company, a foreign company, have copies of our genes, (2) and is that material (our DNA) being held outside Canada? Quite frankly, I don’t want any company to have a copy of my DNA held in some warehouse. But I do know that there are occasions when this is necessary. If you are tested for an illness, they may need to keep a copy of the DNA and the test on file in case you have future health problems or court cases. But, I believe, that information should be kept just for that purpose and only for a limited period of time. If they want my DNA, my body part, for any other purpose they should have to get my written permission. And I mean real consent, not manufactured consent. And I would, of course, insist on knowing (with proof) how the information would be used and who would have access to that information (see next post “Genetic Tests”). Plus, I would want a say in how long they keep my DNA on file. But then again, we live in a illusionary democracy (see post “Why I Don’t Vote – Part II), where I have no say in what happens even to my body parts/information.
CHEO’s CEO Alex Munter said: “We hope to obtain guidance from Canada’s Federal Court that will allow all provinces to approve genetic tests conducted by Canadian healthcare providers. Our patients deserve nothing less”. (6) I believe patients deserve nothing less than to be treated with respect and asked for real consent before genetic tests are performed. And that real consent is based on being informed as to what tests are going to be done, by whom, for what purpose, how that information will be protected, will any of it be patentable and what do these people getting my information/body parts get out of it (wages, profits, royalties….). And this would need to be provided in writing so the patient can give their signed consent or not. Particularly as “Genetics is poised to make major advances” Dr. Gail Graham, chief of the genetics program at CHEO, said”. (6) These people in the medical/research business have proven they cannot be trusted so they must be held accountable with OUR VERY sensitive information. And especially because the BC government has already been in discussions to sell our information (and I suspect are already doing it). (7)
Myriad Genetics and HSC Research and Development Limited have filed a court case against Ambry Genetics, a “company seeking to offer a cheaper test for the breast cancer susceptibility genes”. “HSC Research and Development Limited,” is a legal entity controlled by SickKids in Toronto. It acts as the hospital’s licensing arm for the commercialization of intellectual property. (4)
“Luigi Palombi, an Australian lawyer and author of a book about the race to discover and patent the BRCA gene mutations, states: ‘I think it is outrageous for any publicly funded research institution to be put in this situation.’”(4) It brings forward this whole issue of just how far publicly funded research and research institutions can collaborate with private industry. (3) It is all well and good for politicians to say that we need to encourage commercialization and we need to encourage public institutions to partner with commercial institutions.(3) But it is inevitable once they have come to this sort of arrangement with a commercial entity, and Myriad’s modus operandi from the very beginning was, ‘We are going to patent these genetic mutations because we want to make money out of it.’ (4) Once you have publicly funded institutions getting into bed with these guys, well then that raises a whole series of other questions and issues,” Palombi said.”I think the Canadian public and tax payers have the right to question and find out how this happened, why and what it means for them.”(4) I would like transparency and accountability on how our information is being used. I am not a lab rat, I am not fodder for cannibals to feed off, to commercialize. Or, at least, I don’t want to be but I don’t have a say in the matter; they just take want they want from my body when I am sick and vulnerable.
People, especially researchers and government, will tell you the value of anonymized research data. (10) And, I believe this is true, to a point. But, as we know from the post auditor general – PARIS report – 5/24/2010 and the BC health firings scandal, post dated 12/27/2015, our information is not anonymized and it is certainly not protected. In most cases, government/medical business had no idea who was downloading our information or with whom it was being shared (or so they say). In other cases, where the government/medical business knew who was accessing our information, the information was being shared illegally.
Another issue is that if you collect enough information on an individual, even if it is all anonymous or de-identified, you will be able to identify, or re-identify, the person. In some cases it is not difficult to identify the individual and, in other cases, it takes a great deal of work. But, as technology advances, identifying people from a collection of anonymous or de-identified information will become easier. (8,9)
If we, the citizens, are to benefit from any research/studies involving our body parts and our information, then we need to know the costs of sharing that information (and not just monetarily) and the benefits expected to be gained. So far, we have no idea how our body parts, and our information, are being used. I consider that a gross violation of my rights. In addition, isn’t selling/trading/bartering our DNA, a part of our body, illegal? Isn’t this the same as trafficking in body parts, an international crime? Or do you call it pimping when they are selling your body?
See blog “Newborn Blood Samples”, June 16, 2011 to read more about the dark side of DNA collecting.
Some other interesting information came to light:
(a) “two Canadian researchers were on the winning side in the race to discover the BRCA2 gene mutation back in 1995, and their research institutions share ownership of several U.S. patents with Myriad Genetics.” (4)
(b) these institutions receive royalties and ”That money is ‘critical to these institutions, the majority of which are publicly funded research universities and a children’s hospital, the Hospital for Sick Children located in Toronto, Canada,’ the documents allege, adding that if SickKids and the universities lose royalties from the company’s monopoly on the cancer gene tests, it will ‘impact their ability to fund ongoing programs and new endeavors’.” (4) So how is it that when publicly funded institutions make a discovery, the patent is in the name of its licensing arm and all royalties go to the institution and not the government (on behalf of the people who paid for the research)? With a monopoly they can charge the people more for the tests, which the people paid to develop, and the money goes to the institution to use as they chose. So, the institutions are just milking the people.
I would like to think that CHEO is going to court for altruistic reasons, solely for the care of the patients but I doubt it. Look at the timing. For at least 20 years (3) the Canadian medical system has ignored DNA patenting. Now, just after all the bad publicity about privacy breaches (especially Ontario and B.C.), some medical people are attempting to do something that puts them in a good light. Is this mainly PR? Or, is it because genetics research has progressed to the point that it is very profitable? Now, as I said before, I hope CHEO wins. But will our information, including our DNA, be sold/traded/bartered with THEIR low-life friends. Maybe they should spend time explaining what they do with our information, with whom they share our information, how they are protecting our privacy, or, at least, being honest about how our privacy is not being protected and what they get out of it. But that wouldn’t be in their interests.
IT’S YOUR DNA AND IT DOESN’T GET ANY MORE PERSONAL THAN THAT. (Michelle Salas)
Some other points of interest:
- Police are now trying to collect DNA illegally (13). I wonder with whom that DNA would be shared. Oh that’s right, we don’t have the right to know.
- “The courts may be the final barrier to protect Canadians from unfettered genetic experimentation as scientists abandon public interest research in favour of corporate funding and ambitious, cutting-edge science, lawyers heard yesterday.
The independent scientist who conducts research for the public good ‘barely exists any more,’ according to one leading expert on technology and public policy.
‘They get up and talk as if they are neutral. But they almost always have some share in the company or some self-interested gain for their work,’ said Philip Bereano, a professor from the University of Washington in Seattle.
Genetically modified foods and health care based on genetic research are being introduced into North America by stealth, with large companies using patent law as a weapon against farmers, consumers and patients, panel members said. Billions of government dollars will be spent to modify genes…. “ (14)
- Applied genetic research is emerging as the greatest single driver of global economic growth since the industrial revolution…. “If you are ignoring these trends, you’re ignoring the biggest databases ever generated by mankind.” (15) So, exactly who is profiting from our bodies? And what are they doing to us?
- Tartu, a pretty university town in northern Estonia, is about to become home to the world’s largest genotype and phenotype bank. This bank’s currency will be blood samples and DNA analysis.
In larger countries, it would be more difficult to enact the necessary legislation for such a project, he said, but “in a small country, we can explain it to the people and adopt the law in [a short] time, which we did. British Columbia didn’t have a problem but, of course, they didn’t explain it to the people; B.C. just enacted a law allowing them to take people’s DNA, and anything else, when the people get healthcare, which happens to almost everyone at some time (and probably when they give blood).
“Start-ups and spin-offs will result in a new economic sector,” he said, “with lots of well-paid jobs in the high-tech sector: gene and biotechnology, bioinformatics, etc.
The foundation proposes to map genetic data of at least three-quarters of the 1.4 million people of Estonia.
Such projects have often run into criticism. What if sensitive information falls into the wrong hands? Could employers and insurers discriminate against people thought to be at genetic risk for disease?
Iceland’s deCode genetics project is the most controversial of all. In a deal with European pharmaceutical company Hoffman Laroche, deCode has exclusive rights to all Icelanders’ medical and genetic data, and any resulting intellectual property”. (16) (17)
- 13. Conflict of interest – “…Just look at the conflict of interest statement in any pharmacogenomics journal today and you will find that the head of each of the major studies and a select group of investigators, funded by public tax payers money from NIH, and YOUR DNA, are going to make huge profits from royalties and huge salaries these physicians-researchers earn because they control proprietary samples that are otherwise hard to come by. Just by tying a SNP to a treatment outcome or diagnostic outcome, there are big profits in the healthcare business to be made; with no real innovation! Hence, one wonders about the real motivation underlying collection of blood samples with consent and especially without consent – a cure or a profit!” (12)
- “The administration at UBC, where drug research money abounds and where the Dean of Medicine, incredibly, sits on the board of LifeSciences British Columbia, the main lobby group for BC’s pharmaceutical industry, doesn’t seem to be too worried about our pancreases”. – Diabetes Mongering a dangerous deception – Alan Cassels, July 2013, Common Ground, pg. 13 And round and round the same people go, conflict of interest abounding.
- “According to US consumer group Public Citizen, ‘The pharmaceutical industry now tops not only the defense industry, but all other industries in the total amount of fraud payments for actions against the [US] federal government under the False Claims Act.'”
- “Remember this: money has the ability to pollute even the most noble aspects of healthcare”. – Decoding drug lobbyist rhetoric – Alan Cassels, May 2013, Common Ground, pg. 7
- Genome News Network
- Hospital launches legal challenge to patents on genes – Andre Picard, 4 Nov 2014, The Globe and Mail
- Breast cancer gene patents: the Canadian story – Kelly Crowe, 18 Jul 2013, CBC News
- Sick Kids Hospital dragged into U.S. Breast cancer gene suit – Kelly Crowe, 18 Jul 2013, CBC News
- Legal fight over breast cancer gene begins – 08 Jun 2012, CBC News [no journalist name given]
- Ontario hospital launches lawsuit against owners of gene patent – Marlene Leung, 3 Nov 2014, CBC News
- At Time of Firings, Health Ministry Discussed Selling Patient Data – Andrew MacLeod – 20 Mar 2015, TheTyee.ca
- 8. No silver bullet: De-identification still doesn’t work – Arind Narayanan & Edward W. Felten, July 9, 2014, http://randomwalker.info/publications/no-silver-bullet-de-indentification.pdf
- Identifying Participants in the Personal Genome Project by Name – http://dataprivacylab.org/projects/pgp/index.html
- Tragedy of the Data Commons. Jane Yakowitz, Harvard Journal of Law & Technology, Volume 25, Number 1 Fall 2011
- Gene. Wikipedia
- A Cure or A Profit – Council of Canadians
- Native Youth Leader Resigns Over “Unusual” Police DNA Demand – David P. Ball, 22 Aug 2013, 24 Hours
- Courts protect public against scientific “elite” – 14 Aug 2001, National Post
- Genomes to fuel economic ‘revolution’ – Michael Lewis, 31 May 2002, Financial Post
- Estonians bet on gene pool – Maeve Haldane, 11 Jun 2001, National Post
- Estonia sells its gene pool (A genetic database project is an ethical timebomb) – Michael Gross, 09 Nov 2000, The Guardian