Tag Archives: Timothy Caulfield

Want a free course in science literacy? The University of Alberta has one for you

The folks at the University of Alberta have created a course for learning critical thinking skills where science is concerned. An Oct. 24, 2020 article by Nicole Bergot for the Edmonton Journal describes the course,

“The purpose of this course is to teach people about the process of science and how it is used to acquire knowledge,” course host Claire Scavuzzo, researcher in the Department of Psychology, said in a release. “By the end of the course, learners will be able to understand and use scientific evidence to challenge claims based on misinformation and engage the process of science to ask questions to build our knowledge.”

“With the uncertainty that comes with the current global COVID-19 pandemic we are seeing a general public distrust in science; ironically because of its self-correcting process,” said Scavuzzo.

The online course has no prerequisites, features guest lecturers, and can be completed at the learner’s own pace — roughly five weeks, with five to seven hours per week of study.

The five modules of the course are presented with practice quizzes, reflective quizzes, and interactive learning objects that are all available for free.

A University of Alberta Oct. 13, 2020 news release provides more detail,

We are often told not to believe everything we read online or see on TV—but how do we tell the difference between sensationalized statistics and a real scientific study? A new online course in Science Literacy offered by the University of Alberta is ready to help learners spot sound science—an increasingly relevant skill in today’s world of social media.

The course covers a variety of topics, Scavuzzo explained, and students will have the opportunity to learn how holistic wisdom is gained and practiced by Canadian First Nations, Indigenous, and Metis peoples, compared to the westernized process of science. They will also learn how to think critically about scientific claims from a variety of sources, learning how to differentiate science from pseudoscience.

“Students can expect to finish this course with well-polished critical thinking skills. Rather than ‘science knowledge’ students will build the skill of thinking scientifically, so they are ready to engage in the process of science,” said Scavuzzo. “It may expose some of your biases and it may also help you recognize the value of challenging your biases by being skeptical, asking questions, and evaluating evidence. It will change the way you interact with and absorb content on social media. It will make you realize that these skills can—and should—be used every day.”

Here’s the list of guest lecturers (from the University of Alberta Oct. 13, 2020 news release),

  • Timothy Caulfield, Canada Research Chair in Health Law and Policy and star of Netflix’s “A User’s Guide to Cheating Death” on pseudoscience
  • Dr. Torah Kachur, Scientist and CBC journalist on science communication (and miscommunication!)
  • Christian Nelson, citizen scientist and creator of Edmonton Weather Nerdery, on experimental design
  • Cree Elder Kokum Rose Wabasca on how traditional knowledge is used in indigenous practices.
  • Métis Elder Elmer Ghostkeeper on how indigenous knowledge informs scientific discovery.
  • Dr. David Rast, scientist and psychology expert, on uncertainty and decision making

You can get more details about this Science Literacy Massive Online Open Course (MOOC) here (scroll down to the bottom of the page for the Module Overview) and to click on the registration link. There’s one other thing, you can get certified in Science Literacy should you choose that option.

Gene editing and personalized medicine: Canada

Back in the fall of 2018 I came across one of those overexcited pieces about personalized medicine and gene editing tha are out there. This one came from an unexpected source, an author who is a “PhD Scientist in Medical Science (Blood and Vasculature” (from Rick Gierczak’s LinkedIn profile).

It starts our promisingly enough although I’m beginning to dread the use of the word ‘precise’  where medicine is concerned, (from a September 17, 2018 posting on the Science Borealis blog by Rick Gierczak (Note: Links have been removed),

CRISPR-Cas9 technology was accidentally discovered in the 1980s when scientists were researching how bacteria defend themselves against viral infection. While studying bacterial DNA called clustered regularly interspaced short palindromic repeats (CRISPR), they identified additional CRISPR-associated (Cas) protein molecules. Together, CRISPR and one of those protein molecules, termed Cas9, can locate and cut precise regions of bacterial DNA. By 2012, researchers understood that the technology could be modified and used more generally to edit the DNA of any plant or animal. In 2015, the American Association for the Advancement of Science chose CRISPR-Cas9 as science’s “Breakthrough of the Year”.

Today, CRISPR-Cas9 is a powerful and precise gene-editing tool [emphasis mine] made of two molecules: a protein that cuts DNA (Cas9) and a custom-made length of RNA that works like a GPS for locating the exact spot that needs to be edited (CRISPR). Once inside the target cell nucleus, these two molecules begin editing the DNA. After the desired changes are made, they use a repair mechanism to stitch the new DNA into place. Cas9 never changes, but the CRISPR molecule must be tailored for each new target — a relatively easy process in the lab. However, it’s not perfect, and occasionally the wrong DNA is altered [emphasis mine].

Note that Gierczak makes a point of mentioning that CRISPR/Cas9 is “not perfect.” And then, he gets excited (Note: Links have been removed),

CRISPR-Cas9 has the potential to treat serious human diseases, many of which are caused by a single “letter” mutation in the genetic code (A, C, T, or G) that could be corrected by precise editing. [emphasis mine] Some companies are taking notice of the technology. A case in point is CRISPR Therapeutics, which recently developed a treatment for sickle cell disease, a blood disorder that causes a decrease in oxygen transport in the body. The therapy targets a special gene called fetal hemoglobin that’s switched off a few months after birth. Treatment involves removing stem cells from the patient’s bone marrow and editing the gene to turn it back on using CRISPR-Cas9. These new stem cells are returned to the patient ready to produce normal red blood cells. In this case, the risk of error is eliminated because the new cells are screened for the correct edit before use.

The breakthroughs shown by companies like CRISPR Therapeutics are evidence that personalized medicine has arrived. [emphasis mine] However, these discoveries will require government regulatory approval from the countries where the treatment is going to be used. In the US, the Food and Drug Administration (FDA) has developed new regulations allowing somatic (i.e., non-germ) cell editing and clinical trials to proceed. [emphasis mine]

The potential treatment for sickle cell disease is exciting but Gierczak offers no evidence that this treatment or any unnamed others constitute proof that “personalized medicine has arrived.” In fact, Goldman Sachs, a US-based investment bank, makes the case that it never will .

Cost/benefit analysis

Edward Abrahams, president of the Personalized Medicine Coalition (US-based), advocates for personalized medicine while noting in passing, market forces as represented by Goldman Sachs in his May 23, 2018 piece for statnews.com (Note: A link has been removed),

One of every four new drugs approved by the Food and Drug Administration over the last four years was designed to become a personalized (or “targeted”) therapy that zeros in on the subset of patients likely to respond positively to it. That’s a sea change from the way drugs were developed and marketed 10 years ago.

Some of these new treatments have extraordinarily high list prices. But focusing solely on the cost of these therapies rather than on the value they provide threatens the future of personalized medicine.

… most policymakers are not asking the right questions about the benefits of these treatments for patients and society. Influenced by cost concerns, they assume that prices for personalized tests and treatments cannot be justified even if they make the health system more efficient and effective by delivering superior, longer-lasting clinical outcomes and increasing the percentage of patients who benefit from prescribed treatments.

Goldman Sachs, for example, issued a report titled “The Genome Revolution.” It argues that while “genome medicine” offers “tremendous value for patients and society,” curing patients may not be “a sustainable business model.” [emphasis mine] The analysis underlines that the health system is not set up to reap the benefits of new scientific discoveries and technologies. Just as we are on the precipice of an era in which gene therapies, gene-editing, and immunotherapies promise to address the root causes of disease, Goldman Sachs says that these therapies have a “very different outlook with regard to recurring revenue versus chronic therapies.”

Let’s just chew on this one (contemplate)  for a minute”curing patients may not be ‘sustainable business model’!”

Coming down to earth: policy

While I find Gierczak to be over-enthused, he, like Abrahams, emphasizes the importance of new policy, in his case, the focus is Canadian policy. From Gierczak’s September 17, 2018 posting (Note: Links have been removed),

In Canada, companies need approval from Health Canada. But a 2004 law called the Assisted Human Reproduction Act (AHR Act) states that it’s a criminal offence “to alter the genome of a human cell, or in vitroembryo, that is capable of being transmitted to descendants”. The Actis so broadly written that Canadian scientists are prohibited from using the CRISPR-Cas9 technology on even somatic cells. Today, Canada is one of the few countries in the world where treating a disease with CRISPR-Cas9 is a crime.

On the other hand, some countries provide little regulatory oversight for editing either germ or somatic cells. In China, a company often only needs to satisfy the requirements of the local hospital where the treatment is being performed. And, if germ-cell editing goes wrong, there is little recourse for the future generations affected.

The AHR Act was introduced to regulate the use of reproductive technologies like in vitrofertilization and research related to cloning human embryos during the 1980s and 1990s. Today, we live in a time when medical science, and its role in Canadian society, is rapidly changing. CRISPR-Cas9 is a powerful tool, and there are aspects of the technology that aren’t well understood and could potentially put patients at risk if we move ahead too quickly. But the potential benefits are significant. Updated legislation that acknowledges both the risks and current realities of genomic engineering [emphasis mine] would relieve the current obstacles and support a path toward the introduction of safe new therapies.

Criminal ban on human gene-editing of inheritable cells (in Canada)

I had no idea there was a criminal ban on the practice until reading this January 2017 editorial by Bartha Maria Knoppers, Rosario Isasi, Timothy Caulfield, Erika Kleiderman, Patrick Bedford, Judy Illes, Ubaka Ogbogu, Vardit Ravitsky, & Michael Rudnicki for (Nature) npj Regenerative Medicine (Note: Links have been removed),

Driven by the rapid evolution of gene editing technologies, international policy is examining which regulatory models can address the ensuing scientific, socio-ethical and legal challenges for regenerative and personalised medicine.1 Emerging gene editing technologies, including the CRISPR/Cas9 2015 scientific breakthrough,2 are powerful, relatively inexpensive, accurate, and broadly accessible research tools.3 Moreover, they are being utilised throughout the world in a wide range of research initiatives with a clear eye on potential clinical applications. Considering the implications of human gene editing for selection, modification and enhancement, it is time to re-examine policy in Canada relevant to these important advances in the history of medicine and science, and the legislative and regulatory frameworks that govern them. Given the potential human reproductive applications of these technologies, careful consideration of these possibilities, as well as ethical and regulatory scrutiny must be a priority.4

With the advent of human embryonic stem cell research in 1978, the birth of Dolly (the cloned sheep) in 1996 and the Raelian cloning hoax in 2003, the environment surrounding the enactment of Canada’s 2004 Assisted Human Reproduction Act (AHRA) was the result of a decade of polarised debate,5 fuelled by dystopian and utopian visions for future applications. Rightly or not, this led to the AHRA prohibition on a wide range of activities, including the creation of embryos (s. 5(1)(b)) or chimeras (s. 5(1)(i)) for research and in vitro and in vivo germ line alterations (s. 5(1)(f)). Sanctions range from a fine (up to $500,000) to imprisonment (up to 10 years) (s. 60 AHRA).

In Canada, the criminal ban on gene editing appears clear, the Act states that “No person shall knowingly […] alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants;” [emphases mine] (s. 5(1)(f) AHRA). This approach is not shared worldwide as other countries such as the United Kingdom, take a more regulatory approach to gene editing research.1 Indeed, as noted by the Law Reform Commission of Canada in 1982, criminal law should be ‘an instrument of last resort’ used solely for “conduct which is culpable, seriously harmful, and generally conceived of as deserving of punishment”.6 A criminal ban is a suboptimal policy tool for science as it is inflexible, stifles public debate, and hinders responsiveness to the evolving nature of science and societal attitudes.7 In contrast, a moratorium such as the self-imposed research moratorium on human germ line editing called for by scientists in December 20158 can at least allow for a time limited pause. But like bans, they may offer the illusion of finality and safety while halting research required to move forward and validate innovation.

On October 1st, 2016, Health Canada issued a Notice of Intent to develop regulations under the AHRA but this effort is limited to safety and payment issues (i.e. gamete donation). Today, there is a need for Canada to revisit the laws and policies that address the ethical, legal and social implications of human gene editing. The goal of such a critical move in Canada’s scientific and legal history would be a discussion of the right of Canadians to benefit from the advancement of science and its applications as promulgated in article 27 of the Universal Declaration of Human Rights9 and article 15(b) of the International Covenant on Economic, Social and Cultural Rights,10 which Canada has signed and ratified. Such an approach would further ensure the freedom of scientific endeavour both as a principle of a liberal democracy and as a social good, while allowing Canada to be engaged with the international scientific community.

Even though it’s a bit old, I still recommend reading the open access editorial in full, if you have the time.

One last thing abut the paper, the acknowledgements,

Sponsored by Canada’s Stem Cell Network, the Centre of Genomics and Policy of McGill University convened a ‘think tank’ on the future of human gene editing in Canada with legal and ethics experts as well as representatives and observers from government in Ottawa (August 31, 2016). The experts were Patrick Bedford, Janetta Bijl, Timothy Caulfield, Judy Illes, Rosario Isasi, Jonathan Kimmelman, Erika Kleiderman, Bartha Maria Knoppers, Eric Meslin, Cate Murray, Ubaka Ogbogu, Vardit Ravitsky, Michael Rudnicki, Stephen Strauss, Philip Welford, and Susan Zimmerman. The observers were Geneviève Dubois-Flynn, Danika Goosney, Peter Monette, Kyle Norrie, and Anthony Ridgway.

Competing interests

The authors declare no competing interests.

Both McGill and the Stem Cell Network pop up again. A November 8, 2017 article about the need for new Canadian gene-editing policies by Tom Blackwell for the National Post features some familiar names (Did someone have a budget for public relations and promotion?),

It’s one of the most exciting, and controversial, areas of health science today: new technology that can alter the genetic content of cells, potentially preventing inherited disease — or creating genetically enhanced humans.

But Canada is among the few countries in the world where working with the CRISPR gene-editing system on cells whose DNA can be passed down to future generations is a criminal offence, with penalties of up to 10 years in jail.

This week, one major science group announced it wants that changed, calling on the federal government to lift the prohibition and allow researchers to alter the genome of inheritable “germ” cells and embryos.

The potential of the technology is huge and the theoretical risks like eugenics or cloning are overplayed, argued a panel of the Stem Cell Network.

The step would be a “game-changer,” said Bartha Knoppers, a health-policy expert at McGill University, in a presentation to the annual Till & McCulloch Meetings of stem-cell and regenerative-medicine researchers [These meetings were originally known as the Stem Cell Network’s Annual General Meeting {AGM}]. [emphases mine]

“I’m completely against any modification of the human genome,” said the unidentified meeting attendee. “If you open this door, you won’t ever be able to close it again.”

If the ban is kept in place, however, Canadian scientists will fall further behind colleagues in other countries, say the experts behind the statement say; they argue possible abuses can be prevented with good ethical oversight.

“It’s a human-reproduction law, it was never meant to ban and slow down and restrict research,” said Vardit Ravitsky, a University of Montreal bioethicist who was part of the panel. “It’s a sort of historical accident … and now our hands are tied.”

There are fears, as well, that CRISPR could be used to create improved humans who are genetically programmed to have certain facial or other features, or that the editing could have harmful side effects. Regardless, none of it is happening in Canada, good or bad.

In fact, the Stem Cell Network panel is arguably skirting around the most contentious applications of the technology. It says it is asking the government merely to legalize research for its own sake on embryos and germ cells — those in eggs and sperm — not genetic editing of embryos used to actually get women pregnant.

The highlighted portions in the last two paragraphs of the excerpt were written one year prior to the claims by a Chinese scientist that he had run a clinical trial resulting in gene-edited twins, Lulu and Nana. (See my my November 28, 2018 posting for a comprehensive overview of the original furor). I have yet to publish a followup posting featuring the news that the CRISPR twins may have been ‘improved’ more extensively than originally realized. The initial reports about the twins focused on an illness-related reason (making them HIV ‘immune’) but made no mention of enhanced cognitive skills a side effect of eliminating the gene that would make them HIV ‘immune’. To date, the researcher has not made the bulk of his data available for an in-depth analysis to support his claim that he successfully gene-edited the twins. As well, there were apparently seven other pregnancies coming to term as part of the researcher’s clinical trial and there has been no news about those births.

Risk analysis innovation

Before moving onto the innovation of risk analysis, I want to focus a little more on at least one of the risks that gene-editing might present. Gierczak noted that CRISPR/Cas9 is “not perfect,” which acknowledges the truth but doesn’t convey all that much information.

While the terms ‘precision’ and ‘scissors’ are used frequently when describing the CRISPR technique, scientists actually mean that the technique is significantly ‘more precise’ than other techniques but they are not referencing an engineering level of precision. As for the ‘scissors’, it’s an analogy scientists like to use but in fact CRISPR is not as efficient and precise as a pair of scissors.

Michael Le Page in a July 16, 2018 article for New Scientist lays out some of the issues (Note: A link has been removed),

A study of CRIPSR suggests we shouldn’t rush into trying out CRISPR genome editing inside people’s bodies just yet. The technique can cause big deletions or rearrangements of DNA [emphasis mine], says Allan Bradley of the Wellcome Sanger Institute in the UK, meaning some therapies based on CRISPR may not be quite as safe as we thought.

The CRISPR genome editing technique is revolutionising biology, enabling us to create new varieties of plants and animals and develop treatments for a wide range of diseases.

The CRISPR Cas9 protein works by cutting the DNA of a cell in a specific place. When the cell repairs the damage, a few DNA letters get changed at this spot – an effect that can be exploited to disable genes.

At least, that’s how it is supposed to work. But in studies of mice and human cells, Bradley’s team has found that in around a fifth of cells, CRISPR causes deletions or rearrangements more than 100 DNA letters long. These surprising changes are sometimes thousands of letters long.

“I do believe the findings are robust,” says Gaetan Burgio of the Australian National University, an expert on CRISPR who has debunked previous studies questioning the method’s safety. “This is a well-performed study and fairly significant.”

I covered the Bradley paper and the concerns in a July 17, 2018 posting ‘The CRISPR ((clustered regularly interspaced short palindromic repeats)-CAS9 gene-editing technique may cause new genetic damage kerfuffle‘. (The ‘kerfufle’ was in reference to a report that the CRISPR market was affected by the publication of Bradley’s paper.)

Despite Health Canada not moving swiftly enough for some researchers, they have nonetheless managed to release an ‘outcome’ report about a consultation/analysis started in October 2016. Before getting to the consultation’s outcome, it’s interesting to look at how the consultation’s call for response was described (from Health Canada’s Toward a strengthened Assisted Human Reproduction Act ; A Consultation with Canadians on Key Policy Proposals webpage),

In October 2016, recognizing the need to strengthen the regulatory framework governing assisted human reproduction in Canada, Health Canada announced its intention to bring into force the dormant sections of the Assisted Human Reproduction Act  and to develop the necessary supporting regulations.

This consultation document provides an overview of the key policy proposals that will help inform the development of regulations to support bringing into force Section 10, Section 12 and Sections 45-58 of the Act. Specifically, the policy proposals describe the Department’s position on the following:

Section 10: Safety of Donor Sperm and Ova

  • Scope and application
  • Regulated parties and their regulatory obligations
  • Processing requirements, including donor suitability assessment
  • Record-keeping and traceability

Section 12: Reimbursement

  • Expenditures that may be reimbursed
  • Process for reimbursement
  • Creation and maintenance of records

Sections 45-58: Administration and Enforcement

  • Scope of the administration and enforcement framework
  • Role of inspectors designated under the Act

The purpose of the document is to provide Canadians with an opportunity to review the policy proposals and to provide feedback [emphasis mine] prior to the Department finalizing policy decisions and developing the regulations. In addition to requesting stakeholders’ general feedback on the policy proposals, the Department is also seeking input on specific questions, which are included throughout the document.

It took me a while to find the relevant section (in particular, take note of ‘Federal Regulatory Oversight’),

3.2. AHR in Canada Today

Today, an increasing number of Canadians are turning to AHR technologies to grow or build their families. A 2012 Canadian studyFootnote 1 found that infertility is on the rise in Canada, with roughly 16% of heterosexual couples experiencing infertility. In addition to rising infertility, the trend of delaying marriage and parenthood, scientific advances in cryopreserving ova, and the increasing use of AHR by LGBTQ2 couples and single parents to build a family are all contributing to an increase in the use of AHR technologies.

The growing use of reproductive technologies by Canadians to help build their families underscores the need to strengthen the AHR Act. While the approach to regulating AHR varies from country to country, Health Canada has considered international best practices and the need for regulatory alignment when developing the proposed policies set out in this document. …

3.2.1 Federal Regulatory Oversight

Although the scope of the AHR Act was significantly reduced in 2012 and some of the remaining sections have not yet been brought into force, there are many important sections of the Act that are currently administered and enforced by Health Canada, as summarized generally below:

Section 5: Prohibited Scientific and Research Procedures
Section 5 prohibits certain types of scientific research and clinical procedures that are deemed unacceptable, including: human cloning, the creation of an embryo for non-reproductive purposes, maintaining an embryo outside the human body beyond the fourteenth day, sex selection for non-medical reasons, altering the genome in a way that could be transmitted to descendants, and creating a chimera or a hybrid. [emphasis mine]

….

It almost seems as if the they were hiding the section that broached the human gene-editing question. It doesn’t seem to have worked as it appears, there are some very motivated parties determined to reframe the discussion. Health Canada’s ‘outocme’ report, published March 2019, What we heard: A summary of scanning and consultations on what’s next for health product regulation reflects the success of those efforts,

1.0 Introduction and Context

Scientific and technological advances are accelerating the pace of innovation. These advances are increasingly leading to the development of health products that are better able to predict, define, treat, and even cure human diseases. Globally, many factors are driving regulators to think about how to enable health innovation. To this end, Health Canada has been expanding beyond existing partnerships and engaging both domestically and internationally. This expanding landscape of products and services comes with a range of new challenges and opportunities.

In keeping up to date with emerging technologies and working collaboratively through strategic partnerships, Health Canada seeks to position itself as a regulator at the forefront of health innovation. Following the targeted sectoral review of the Health and Biosciences Sector Regulatory Review consultation by the Treasury Board Secretariat, Health Canada held a number of targeted meetings with a broad range of stakeholders.

This report outlines the methodologies used to look ahead at the emerging health technology environment, [emphasis mine] the potential areas of focus that resulted, and the key findings from consultations.

… the Department identified the following key drivers that are expected to shape the future of health innovation:

  1. The use of “big data” to inform decision-making: Health systems are generating more data, and becoming reliant on this data. The increasing accuracy, types, and volume of data available in real time enable automation and machine learning that can forecast activity, behaviour, or trends to support decision-making.
  2. Greater demand for citizen agency: Canadians increasingly want and have access to more information, resources, options, and platforms to manage their own health (e.g., mobile apps, direct-to-consumer services, decentralization of care).
  3. Increased precision and personalization in health care delivery: Diagnostic tools and therapies are increasingly able to target individual patients with customized therapies (e.g., individual gene therapy).
  4. Increased product complexity: Increasingly complex products do not fit well within conventional product classifications and standards (e.g., 3D printing).
  5. Evolving methods for production and distribution: In some cases, manufacturers and supply chains are becoming more distributed, challenging the current framework governing production and distribution of health products.
  6. The ways in which evidence is collected and used are changing: The processes around new drug innovation, research and development, and designing clinical trials are evolving in ways that are more flexible and adaptive.

With these key drivers in mind, the Department selected the following six emerging technologies for further investigation to better understand how the health product space is evolving:

  1. Artificial intelligence, including activities such as machine learning, neural networks, natural language processing, and robotics.
  2. Advanced cell therapies, such as individualized cell therapies tailor-made to address specific patient needs.
  3. Big data, from sources such as sensors, genetic information, and social media that are increasingly used to inform patient and health care practitioner decisions.
  4. 3D printing of health products (e.g., implants, prosthetics, cells, tissues).
  5. New ways of delivering drugs that bring together different product lines and methods (e.g., nano-carriers, implantable devices).
  6. Gene editing, including individualized gene therapies that can assist in preventing and treating certain diseases.

Next, to test the drivers identified and further investigate emerging technologies, the Department consulted key organizations and thought leaders across the country with expertise in health innovation. To this end, Health Canada held seven workshops with over 140 representatives from industry associations, small-to-medium sized enterprises and start-ups, larger multinational companies, investors, researchers, and clinicians in Ottawa, Toronto, Montreal, and Vancouver. [emphases mine]

The ‘outocme’ report, ‘What we heard …’, is well worth reading in its entirety; it’s about 9 pp.

I have one comment, ‘stakeholders’ don’t seem to include anyone who isn’t “from industry associations, small-to-medium sized enterprises and start-ups, larger multinational companies, investors, researchers, and clinician” or from “Ottawa, Toronto, Montreal, and Vancouver.” Aren’t the rest of us stakeholders?

Innovating risk analysis

This line in the report caught my eye (from Health Canada’s Toward a strengthened Assisted Human Reproduction Act ; A Consultation with Canadians on Key Policy Proposals webpage),

There is increasing need to enable innovation in a flexible, risk-based way, with appropriate oversight to ensure safety, quality, and efficacy. [emphases mine]

It reminded me of the 2019 federal budget (from my March 22, 2019 posting). One comment before proceeding, regulation and risk are tightly linked and, so, by innovating regulation they are by exttension alos innovating risk analysis,

… Budget 2019 introduces the first three “Regulatory Roadmaps” to specifically address stakeholder issues and irritants in these sectors, informed by over 140 responses [emphasis mine] from businesses and Canadians across the country, as well as recommendations from the Economic Strategy Tables.

Introducing Regulatory Roadmaps

These Roadmaps lay out the Government’s plans to modernize regulatory frameworks, without compromising our strong health, safety, and environmental protections. They contain proposals for legislative and regulatory amendments as well as novel regulatory approaches to accommodate emerging technologies, including the use of regulatory sandboxes and pilot projects—better aligning our regulatory frameworks with industry realities.

Budget 2019 proposes the necessary funding and legislative revisions so that regulatory departments and agencies can move forward on the Roadmaps, including providing the Canadian Food Inspection Agency, Health Canada and Transport Canada with up to $219.1 million over five years, starting in 2019–20, (with $0.5 million in remaining amortization), and $3.1 million per year on an ongoing basis.

In the coming weeks, the Government will be releasing the full Regulatory Roadmaps for each of the reviews, as well as timelines for enacting specific initiatives, which can be grouped in the following three main areas:

What Is a Regulatory Sandbox? Regulatory sandboxes are controlled “safe spaces” in which innovative products, services, business models and delivery mechanisms can be tested without immediately being subject to all of the regulatory requirements.
– European Banking Authority, 2017

Establishing a regulatory sandbox for new and innovative medical products
The regulatory approval system has not kept up with new medical technologies and processes. Health Canada proposes to modernize regulations to put in place a regulatory sandbox for new and innovative products, such as tissues developed through 3D printing, artificial intelligence, and gene therapies targeted to specific individuals. [emphasis mine]

Modernizing the regulation of clinical trials
Industry and academics have expressed concerns that regulations related to clinical trials are overly prescriptive and inconsistent. Health Canada proposes to implement a risk-based approach [emphasis mine] to clinical trials to reduce costs to industry and academics by removing unnecessary requirements for low-risk drugs and trials. The regulations will also provide the agri-food industry with the ability to carry out clinical trials within Canada on products such as food for special dietary use and novel foods.

Does the government always get 140 responses from a consultation process? Moving on, I agree with finding new approaches to regulatory processes and oversight and, by extension, new approaches to risk analysis.

Earlier in this post, I asked if someone had a budget for public relations/promotion. I wasn’t joking. My March 22, 2019 posting also included these line items in the proposed 2019 budget,

Budget 2019 proposes to make additional investments in support of the following organizations:
Stem Cell Network: Stem cell research—pioneered by two Canadians in the 1960s [James Till and Ernest McCulloch]—holds great promise for new therapies and medical treatments for respiratory and heart diseases, spinal cord injury, cancer, and many other diseases and disorders. The Stem Cell Network is a national not-for-profit organization that helps translate stem cell research into clinical applications and commercial products. To support this important work and foster Canada’s leadership in stem cell research, Budget 2019 proposes to provide the Stem Cell Network with renewed funding of $18 million over three years, starting in 2019–20.

Genome Canada: The insights derived from genomics—the study of the entire genetic information of living things encoded in their DNA and related molecules and proteins—hold the potential for breakthroughs that can improve the lives of Canadians and drive innovation and economic growth. Genome Canada is a not-for-profit organization dedicated to advancing genomics science and technology in order to create economic and social benefits for Canadians. To support Genome Canada’s operations, Budget 2019 proposes to provide Genome Canada with $100.5 million over five years, starting in 2020–21. This investment will also enable Genome Canada to launch new large-scale research competitions and projects, in collaboration with external partners, ensuring that Canada’s research community continues to have access to the resources needed to make transformative scientific breakthroughs and translate these discoveries into real-world applications.

Years ago, I managed to find a webpage with all of the proposals various organizations were submitting to a government budget committee. It was eye-opening. You can tell which organizations were able to hire someone who knew the current government buzzwords and the things that a government bureaucrat would want to hear and the organizations that didn’t.

Of course, if the government of the day is adamantly against or uninterested, no amount of persusasion will work to get your organization more money in the budget.

Finally

Reluctantly, I am inclined to explore the topic of emerging technologies such as gene-editing not only in the field of agriculture (for gene-editing of plants, fish, and animals see my November 28, 2018 posting) but also with humans. At the very least, it needs to be discussed whether we choose to participate or not.

If you are interested in the arguments against changing Canada’s prohibition against gene-editing of humans, there’s an Ocotber 2, 2017 posting on Impact Ethics by Françoise Baylis, Professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University, and Alana Cattapan, Johnson Shoyama Graduate School of Public Policy at the University of Saskatchewan, which makes some compelling arguments. Of course, it was written before the CRISPR twins (my November 28, 2018 posting).

Recaliing CRISPR Therapeutics (mentioned by Gierczak), the company received permission to run clinical trials in the US in October 2018 after the FDA (US Food and Drug Administration) lifted an earlier ban on their trials according to an Oct. 10, 2018 article by Frank Vinhuan for exome,

The partners also noted that their therapy is making progress outside of the U.S. They announced that they have received regulatory clearance in “multiple countries” to begin tests of the experimental treatment in both sickle cell disease and beta thalassemia, …

It seems to me that the quotes around “multiple countries” are meant to suggest doubt of some kind. Generally speaking, company representatives make those kinds of generalizations when they’re trying to pump up their copy. E.g., 50% increase in attendance  but no whole numbers to tell you what that means. It could mean two people attended the first year and then brought a friend the next year or 100 people attended and the next year there were 150.

Despite attempts to declare personalized medicine as having arrived, I think everything is still in flux with no preordained outcome. The future has yet to be determined but it will be and I , for one, would like to have some say in the matter.

Why don’t you CRISPR yourself?

It must have been quite the conference. Josiah Zayner plunged a needle into himself and claimed to have changed his DNA (deoxyribonucleic acid) while giving his talk. (*Segue: There is some Canadian content if you keep reading.*) From an Oct. 10, 2017 article by Adele Peters for Fast Company (Note: A link has been removed),

“What we’ve got here is some DNA, and this is a syringe,” Josiah Zayner tells a room full of synthetic biologists and other researchers. He fills the needle and plunges it into his skin. “This will modify my muscle genes and give me bigger muscles.”

Zayner, a biohacker–basically meaning he experiments with biology in a DIY lab rather than a traditional one–was giving a talk called “A Step-by-Step Guide to Genetically Modifying Yourself With CRISPR” at the SynBioBeta conference in San Francisco, where other presentations featured academics in suits and the young CEOs of typical biotech startups. Unlike the others, he started his workshop by handing out shots of scotch and a booklet explaining the basics of DIY [do-it-yourwelf] genome engineering.

If you want to genetically modify yourself, it turns out, it’s not necessarily complicated. As he offered samples in small baggies to the crowd, Zayner explained that it took him about five minutes to make the DNA that he brought to the presentation. The vial held Cas9, an enzyme that snips DNA at a particular location targeted by guide RNA, in the gene-editing system known as CRISPR. In this case, it was designed to knock out the myostatin gene, which produces a hormone that limits muscle growth and lets muscles atrophy. In a study in China, dogs with the edited gene had double the muscle mass of normal dogs. If anyone in the audience wanted to try it, they could take a vial home and inject it later. Even rubbing it on skin, Zayner said, would have some effect on cells, albeit limited.

Peters goes on to note that Zayner has a PhD in molecular biology and biophysics and worked for NASA (US National Aeronautics and Space Administration). Zayner’s Wikipedia entry fills in a few more details (Note: Links have been removed),

Zayner graduated from the University of Chicago with a Ph.D. in biophysics in 2013. He then spent two years as a researcher at NASA’s Ames Research Center,[2] where he worked on Martian colony habitat design. While at the agency, Zayner also analyzed speech patterns in online chat, Twitter, and books, and found that language on Twitter and online chat is closer to how people talk than to how they write.[3] Zayner found NASA’s scientific work less innovative than he expected, and upon leaving in January 2016, he launched a crowdfunding campaign to provide CRISPR kits to let the general public experiment with editing bacterial DNA. He also continued his grad school business, The ODIN, which sells kits to let the general public experiment at home. As of May 2016, The ODIN had four employees and operates out of Zayner’s garage.[2]

He refers to himself as a biohacker and believes in the importance in letting the general public participate in scientific experimentation, rather than leaving it segregated to labs.[2][4][1] Zayner found the biohacking community exclusive and hierarchical, particularly in the types of people who decide what is “safe”. He hopes that his projects can let even more people experiment in their homes. Other scientists responded that biohacking is inherently privileged, as it requires leisure time and money, and that deviance from the safety rules of concern would lead to even harsher regulations for all.[5] Zayner’s public CRISPR kit campaign coincided with wider scrutiny over genetic modification. Zayner maintained that these fears were based on misunderstandings of the product, as genetic experiments on yeast and bacteria cannot produce a viral epidemic.[6][7] In April 2015, Zayner ran a hoax on Craigslist to raise awareness about the future potential of forgery in forensics genetics testing.[8]

In February 2016, Zayner performed a full body microbiome transplant on himself, including a fecal transplant, to experiment with microbiome engineering and see if he could cure himself from gastrointestinal and other health issues. The microbiome from the donors feces successfully transplanted in Zayner’s gut according to DNA sequencing done on samples.[2] This experiment was documented by filmmakers Kate McLean and Mario Furloni and turned into the short documentary film Gut Hack.[9]

In December 2016, Zayner created a fluorescent beer by engineering yeast to contain the green fluorescent protein from jellyfish. Zayner’s company, The ODIN, released kits to allow people to create their own engineered fluorescent yeast and this was met with some controversy as the FDA declared the green fluorescent protein can be seen as a color additive.[10] Zayner, views the kit as a way that individual can use genetic engineering to create things in their everyday life.[11]

I found the video for Zayner’s now completed crowdfunding campaign,

I also found The ODIN website (mentioned in the Wikipedia essay) where they claim to be selling various gene editing and gene engineering kits including the CRISPR editing kits mentioned in Peters’ article,

In 2016, he [Zayner] sold $200,000 worth of products, including a kit for yeast that can be used to brew glowing bioluminescent beer, a kit to discover antibiotics at home, and a full home lab that’s roughly the cost of a MacBook Pro. In 2017, he expects to double sales. Many kits are simple, and most buyers probably aren’t using the supplies to attempt to engineer themselves (many kits go to classrooms). But Zayner also hopes that as people using the kits gain genetic literacy, they experiment in wilder ways.

Zayner sells a full home biohacking lab that’s roughly the cost of a MacBook Pro. [Photo: The ODIN]

He questions whether traditional research methods, like randomized controlled trials, are the only way to make discoveries, pointing out that in newer personalized medicine (such as immunotherapy for cancer, which is personalized for each patient), a sample size of one person makes sense. At his workshop, he argued that people should have the choice to self-experiment if they want to; we also change our DNA when we drink alcohol or smoke cigarettes or breathe in dirty city air. Other society-sanctioned activities are more dangerous. “We sacrifice maybe a million people a year to the car gods,” he said. “If you ask someone, ‘Would you get rid of cars?’–no.” …

US researchers both conventional and DIY types such as Zayner are not the only ones who are editing genes. The Chinese study mentioned in Peters’ article was written up in an Oct. 19, 2015 article by Antonio Regalado for the MIT [Massachusetts Institute of Technology] Technology Review (Note: Links have been removed),

Scientists in China say they are the first to use gene editing to produce customized dogs. They created a beagle with double the amount of muscle mass by deleting a gene called myostatin.

The dogs have “more muscles and are expected to have stronger running ability, which is good for hunting, police (military) applications,” Liangxue Lai, a researcher with the Key Laboratory of Regenerative Biology at the Guangzhou Institutes of Biomedicine and Health, said in an e-mail.

Lai and 28 colleagues reported their results last week in the Journal of Molecular Cell Biology, saying they intend to create dogs with other DNA mutations, including ones that mimic human diseases such as Parkinson’s and muscular dystrophy. “The goal of the research is to explore an approach to the generation of new disease dog models for biomedical research,” says Lai. “Dogs are very close to humans in terms of metabolic, physiological, and anatomical characteristics.”

Lai said his group had no plans breed to breed the extra-muscular beagles as pets. Other teams, however, could move quickly to commercialize gene-altered dogs, potentially editing their DNA to change their size, enhance their intelligence, or correct genetic illnesses. A different Chinese Institute, BGI, said in September it had begun selling miniature pigs, created via gene editing, for $1,600 each as novelty pets.

People have been influencing the genetics of dogs for millennia. By at least 36,000 years ago, early humans had already started to tame wolves and shape the companions we have today. Charles Darwin frequently cited dog breeding in The Origin of Species to demonstrate how evolution gradually occurs by a process of selection. With CRISPR, however, evolution is no longer gradual or subject to chance. It is immediate and under human control.

It is precisely that power that is stirring wide debate and concern over CRISPR. Yet at least some researchers think that gene-edited dogs could put a furry, friendly face on the technology. In an interview this month, George Church, a professor at Harvard University who leads a large effort to employ CRISPR editing, said he thinks it will be possible to augment dogs by using DNA edits to make them live longer or simply make them smarter.

Church said he also believed the alteration of dogs and other large animals could open a path to eventual gene editing of people. “Germline editing of pigs or dogs offers a line into it,” he said. “People might say, ‘Hey, it works.’ ”

In the meantime, Zayner’s ideas are certainly thought provoking. I’m not endorsing either his products or his ideas but it should be noted that early science pioneers such as Humphrey Davy and others experimented on themselves. For anyone unfamiliar with Davy, (from the Humphrey Davy Wikipedia entry; Note: Links have been removed),

Sir Humphry Davy, 1st Baronet PRS MRIA FGS (17 December 1778 – 29 May 1829) was a Cornish chemist and inventor,[1] who is best remembered today for isolating a series of substances for the first time: potassium and sodium in 1807 and calcium, strontium, barium, magnesium and boron the following year, as well as discovering the elemental nature of chlorine and iodine. He also studied the forces involved in these separations, inventing the new field of electrochemistry. Berzelius called Davy’s 1806 Bakerian Lecture On Some Chemical Agencies of Electricity[2] “one of the best memoirs which has ever enriched the theory of chemistry.”[3] He was a Baronet, President of the Royal Society (PRS), Member of the Royal Irish Academy (MRIA), and Fellow of the Geological Society (FGS). He also invented the Davy lamp and a very early form of incandescent light bulb.

Canadian content*

A Nov. 11, 2017 posting on the Canadian Broadcasting Corporation’s (CBC) Quirks and Quarks blog notes that self-experimentation has a long history and goes on to describe Zayner’s and others biohacking exploits before describing the legality of biohacking in Canada,

With biohackers entering into the space traditionally held by scientists and clinicians, it begs questions. Professor Timothy Caulfield, a Canada research chair in health, law and policy at the University of Alberta, says when he hears of somebody giving themselves biohacked gene therapy, he wonders: “Is this legal? Is this safe? And if it’s not safe, is there anything that we can do about regulating it? And to be honest with you that’s a tough question and I think it’s an open question.”

In Canada, Caulfield says, Health Canada focuses on products. “You have to have something that you are going to regulate or you have to have something that’s making health claims. So if there is a product that is saying I can cure X, Y, or Z, Health Canada can say, ‘Well let’s make sure the science really backs up that claim.’ The problem with these do-it-yourself approaches is there isn’t really a product. You know these people are experimenting on themselves with something that may or may not be designed for health purposes.”

According to Caufield, if you could buy a gene therapy kit that was being marketed to you to biohack yourself, that would be different. “Health Canada could jump in. But right here that’s not the case,” he says.

There are places in the world that do regulate biohacking, says Caulfield. “Germany, for example, they have specific laws for it. And here in Canada we do have a regulatory framework that says that you cannot do gene therapy that will alter the germ line. In other words, you can’t do gene therapy or any kind of genetic editing that will create a change that you will pass on to your offspring. So that would be illegal, but that’s not what’s happening here. And I don’t think there’s a regulatory framework that adequately captures it.”

Infectious disease and policy experts aren’t that concerned yet about the possibility of a biohacker unleashing a genetically modified super germ into the population.

“I think in the future that could be a problem,”says Caulfield, “but this isn’t something that would be easy to do in your garage. I think it’s complicated science. But having said that, the science is moving quickly. We need to think about how we are going to control the potential harms.”

You can find out more about the ‘wild’ people (mostly men) of early science in Richard Holmes’ 2008 book, The Age of Wonder: How the Romantic Generation Discovered the Beauty and Terror of Science.

Finally, should you be interested in connecting with synthetic biology enthusiasts, entrepreneurs, and others, SynBioBeta is more than a conference; it’s also an activity hub.

ETA January 25, 2018 (five minutes later): There are some CRISPR/CAS9 events taking place in Toronto, Canada on January 24 and 25, 2018. One is a workshop with Portuguese artist, Marta de Menezes, and the other is a panel discussion. See my January 10, 2018 posting for more details.

*’Segue: There is some Canadian content if you keep reading.’ and ‘Canadian content’ added January 25, 2018 six minutes after first publication.

ETA February 20, 2018: Sarah Zhang’s Feb. 20, 2018 article for The Atlantic revisits Josiah Zayner’s decision to inject himself with CRISPR,

When Josiah Zayner watched a biotech CEO drop his pants at a biohacking conference and inject himself with an untested herpes treatment, he realized things had gone off the rails.

Zayner is no stranger to stunts in biohacking—loosely defined as experiments, often on the self, that take place outside of traditional lab spaces. You might say he invented their latest incarnation: He’s sterilized his body to “transplant” his entire microbiome in front of a reporter. He’s squabbled with the FDA about selling a kit to make glow-in-the-dark beer. He’s extensively documented attempts to genetically engineer the color of his skin. And most notoriously, he injected his arm with DNA encoding for CRISPR that could theoretically enhance his muscles—in between taking swigs of Scotch at a live-streamed event during an October conference. (Experts say—and even Zayner himself in the live-stream conceded—it’s unlikely to work.)

So when Zayner saw Ascendance Biomedical’s CEO injecting himself on a live-stream earlier this month, you might say there was an uneasy flicker of recognition.

“Honestly, I kind of blame myself,” Zayner told me recently. He’s been in a soul-searching mood; he recently had a kid and the backlash to the CRISPR stunt in October [2017] had been getting to him. “There’s no doubt in my mind that somebody is going to end up hurt eventually,” he said.

Yup, it’s one of the reasons for rules; people take things too far. The trick is figuring out how to achieve balance between risk taking and recklessness.

Vector Institute and Canada’s artificial intelligence sector

On the heels of the March 22, 2017 federal budget announcement of $125M for a Pan-Canadian Artificial Intelligence Strategy, the University of Toronto (U of T) has announced the inception of the Vector Institute for Artificial Intelligence in a March 28, 2017 news release by Jennifer Robinson (Note: Links have been removed),

A team of globally renowned researchers at the University of Toronto is driving the planning of a new institute staking Toronto’s and Canada’s claim as the global leader in AI.

Geoffrey Hinton, a University Professor Emeritus in computer science at U of T and vice-president engineering fellow at Google, will serve as the chief scientific adviser of the newly created Vector Institute based in downtown Toronto.

“The University of Toronto has long been considered a global leader in artificial intelligence research,” said U of T President Meric Gertler. “It’s wonderful to see that expertise act as an anchor to bring together researchers, government and private sector actors through the Vector Institute, enabling them to aim even higher in leading advancements in this fast-growing, critical field.”

As part of the Government of Canada’s Pan-Canadian Artificial Intelligence Strategy, Vector will share $125 million in federal funding with fellow institutes in Montreal and Edmonton. All three will conduct research and secure talent to cement Canada’s position as a world leader in AI.

In addition, Vector is expected to receive funding from the Province of Ontario and more than 30 top Canadian and global companies eager to tap this pool of talent to grow their businesses. The institute will also work closely with other Ontario universities with AI talent.

(See my March 24, 2017 posting; scroll down about 25% for the science part, including the Pan-Canadian Artificial Intelligence Strategy of the budget.)

Not obvious in last week’s coverage of the Pan-Canadian Artificial Intelligence Strategy is that the much lauded Hinton has been living in the US and working for Google. These latest announcements (Pan-Canadian AI Strategy and Vector Institute) mean that he’s moving back.

A March 28, 2017 article by Kate Allen for TorontoStar.com provides more details about the Vector Institute, Hinton, and the Canadian ‘brain drain’ as it applies to artificial intelligence, (Note:  A link has been removed)

Toronto will host a new institute devoted to artificial intelligence, a major gambit to bolster a field of research pioneered in Canada but consistently drained of talent by major U.S. technology companies like Google, Facebook and Microsoft.

The Vector Institute, an independent non-profit affiliated with the University of Toronto, will hire about 25 new faculty and research scientists. It will be backed by more than $150 million in public and corporate funding in an unusual hybridization of pure research and business-minded commercial goals.

The province will spend $50 million over five years, while the federal government, which announced a $125-million Pan-Canadian Artificial Intelligence Strategy in last week’s budget, is providing at least $40 million, backers say. More than two dozen companies have committed millions more over 10 years, including $5 million each from sponsors including Google, Air Canada, Loblaws, and Canada’s five biggest banks [Bank of Montreal (BMO). Canadian Imperial Bank of Commerce ({CIBC} President’s Choice Financial},  Royal Bank of Canada (RBC), Scotiabank (Tangerine), Toronto-Dominion Bank (TD Canada Trust)].

The mode of artificial intelligence that the Vector Institute will focus on, deep learning, has seen remarkable results in recent years, particularly in image and speech recognition. Geoffrey Hinton, considered the “godfather” of deep learning for the breakthroughs he made while a professor at U of T, has worked for Google since 2013 in California and Toronto.

Hinton will move back to Canada to lead a research team based at the tech giant’s Toronto offices and act as chief scientific adviser of the new institute.

Researchers trained in Canadian artificial intelligence labs fill the ranks of major technology companies, working on tools like instant language translation, facial recognition, and recommendation services. Academic institutions and startups in Toronto, Waterloo, Montreal and Edmonton boast leaders in the field, but other researchers have left for U.S. universities and corporate labs.

The goals of the Vector Institute are to retain, repatriate and attract AI talent, to create more trained experts, and to feed that expertise into existing Canadian companies and startups.

Hospitals are expected to be a major partner, since health care is an intriguing application for AI. Last month, researchers from Stanford University announced they had trained a deep learning algorithm to identify potentially cancerous skin lesions with accuracy comparable to human dermatologists. The Toronto company Deep Genomics is using deep learning to read genomes and identify mutations that may lead to disease, among other things.

Intelligent algorithms can also be applied to tasks that might seem less virtuous, like reading private data to better target advertising. Zemel [Richard Zemel, the institute’s research director and a professor of computer science at U of T] says the centre is creating an ethics working group [emphasis mine] and maintaining ties with organizations that promote fairness and transparency in machine learning. As for privacy concerns, “that’s something we are well aware of. We don’t have a well-formed policy yet but we will fairly soon.”

The institute’s annual funding pales in comparison to the revenues of the American tech giants, which are measured in tens of billions. The risk the institute’s backers are taking is simply creating an even more robust machine learning PhD mill for the U.S.

“They obviously won’t all stay in Canada, but Toronto industry is very keen to get them,” Hinton said. “I think Trump might help there.” Two researchers on Hinton’s new Toronto-based team are Iranian, one of the countries targeted by U.S. President Donald Trump’s travel bans.

Ethics do seem to be a bit of an afterthought. Presumably the Vector Institute’s ‘ethics working group’ won’t include any regular folks. Is there any thought to what the rest of us think about these developments? As there will also be some collaboration with other proposed AI institutes including ones at the University of Montreal (Université de Montréal) and the University of Alberta (Kate McGillivray’s article coming up shortly mentions them), might the ethics group be centered in either Edmonton or Montreal? Interestingly, two Canadians (Timothy Caulfield at the University of Alberta and Eric Racine at Université de Montréa) testified at the US Commission for the Study of Bioethical Issues Feb. 10 – 11, 2014 meeting, the Brain research, ethics, and nanotechnology. Still speculating here but I imagine Caulfield and/or Racine could be persuaded to extend their expertise in ethics and the human brain to AI and its neural networks.

Getting back to the topic at hand the ‘AI sceneCanada’, Allen’s article is worth reading in its entirety if you have the time.

Kate McGillivray’s March 29, 2017 article for the Canadian Broadcasting Corporation’s (CBC) news online provides more details about the Canadian AI situation and the new strategies,

With artificial intelligence set to transform our world, a new institute is putting Toronto to the front of the line to lead the charge.

The Vector Institute for Artificial Intelligence, made possible by funding from the federal government revealed in the 2017 budget, will move into new digs in the MaRS Discovery District by the end of the year.

Vector’s funding comes partially from a $125 million investment announced in last Wednesday’s federal budget to launch a pan-Canadian artificial intelligence strategy, with similar institutes being established in Montreal and Edmonton.

“[A.I.] cuts across pretty well every sector of the economy,” said Dr. Alan Bernstein, CEO and president of the Canadian Institute for Advanced Research, the organization tasked with administering the federal program.

“Silicon Valley and England and other places really jumped on it, so we kind of lost the lead a little bit. I think the Canadian federal government has now realized that,” he said.

Stopping up the brain drain

Critical to the strategy’s success is building a homegrown base of A.I. experts and innovators — a problem in the last decade, despite pioneering work on so-called “Deep Learning” by Canadian scholars such as Yoshua Bengio and Geoffrey Hinton, a former University of Toronto professor who will now serve as Vector’s chief scientific advisor.

With few university faculty positions in Canada and with many innovative companies headquartered elsewhere, it has been tough to keep the few graduates specializing in A.I. in town.

“We were paying to educate people and shipping them south,” explained Ed Clark, chair of the Vector Institute and business advisor to Ontario Premier Kathleen Wynne.

The existence of that “fantastic science” will lean heavily on how much buy-in Vector and Canada’s other two A.I. centres get.

Toronto’s portion of the $125 million is a “great start,” said Bernstein, but taken alone, “it’s not enough money.”

“My estimate of the right amount of money to make a difference is a half a billion or so, and I think we will get there,” he said.

Jessica Murphy’s March 29, 2017 article for the British Broadcasting Corporation’s (BBC) news online offers some intriguing detail about the Canadian AI scene,

Canadian researchers have been behind some recent major breakthroughs in artificial intelligence. Now, the country is betting on becoming a big player in one of the hottest fields in technology, with help from the likes of Google and RBC [Royal Bank of Canada].

In an unassuming building on the University of Toronto’s downtown campus, Geoff Hinton laboured for years on the “lunatic fringe” of academia and artificial intelligence, pursuing research in an area of AI called neural networks.

Also known as “deep learning”, neural networks are computer programs that learn in similar way to human brains. The field showed early promise in the 1980s, but the tech sector turned its attention to other AI methods after that promise seemed slow to develop.

“The approaches that I thought were silly were in the ascendancy and the approach that I thought was the right approach was regarded as silly,” says the British-born [emphasis mine] professor, who splits his time between the university and Google, where he is a vice-president of engineering fellow.

Neural networks are used by the likes of Netflix to recommend what you should binge watch and smartphones with voice assistance tools. Google DeepMind’s AlphaGo AI used them to win against a human in the ancient game of Go in 2016.

Foteini Agrafioti, who heads up the new RBC Research in Machine Learning lab at the University of Toronto, said those recent innovations made AI attractive to researchers and the tech industry.

“Anything that’s powering Google’s engines right now is powered by deep learning,” she says.

Developments in the field helped jumpstart innovation and paved the way for the technology’s commercialisation. They also captured the attention of Google, IBM and Microsoft, and kicked off a hiring race in the field.

The renewed focus on neural networks has boosted the careers of early Canadian AI machine learning pioneers like Hinton, the University of Montreal’s Yoshua Bengio, and University of Alberta’s Richard Sutton.

Money from big tech is coming north, along with investments by domestic corporations like banking multinational RBC and auto parts giant Magna, and millions of dollars in government funding.

Former banking executive Ed Clark will head the institute, and says the goal is to make Toronto, which has the largest concentration of AI-related industries in Canada, one of the top five places in the world for AI innovation and business.

The founders also want it to serve as a magnet and retention tool for top talent aggressively head-hunted by US firms.

Clark says they want to “wake up” Canadian industry to the possibilities of AI, which is expected to have a massive impact on fields like healthcare, banking, manufacturing and transportation.

Google invested C$4.5m (US$3.4m/£2.7m) last November [2016] in the University of Montreal’s Montreal Institute for Learning Algorithms.

Microsoft is funding a Montreal startup, Element AI. The Seattle-based company also announced it would acquire Montreal-based Maluuba and help fund AI research at the University of Montreal and McGill University.

Thomson Reuters and General Motors both recently moved AI labs to Toronto.

RBC is also investing in the future of AI in Canada, including opening a machine learning lab headed by Agrafioti, co-funding a program to bring global AI talent and entrepreneurs to Toronto, and collaborating with Sutton and the University of Alberta’s Machine Intelligence Institute.

Canadian tech also sees the travel uncertainty created by the Trump administration in the US as making Canada more attractive to foreign talent. (One of Clark’s the selling points is that Toronto as an “open and diverse” city).

This may reverse the ‘brain drain’ but it appears Canada’s role as a ‘branch plant economy’ for foreign (usually US) companies could become an important discussion once more. From the ‘Foreign ownership of companies of Canada’ Wikipedia entry (Note: Links have been removed),

Historically, foreign ownership was a political issue in Canada in the late 1960s and early 1970s, when it was believed by some that U.S. investment had reached new heights (though its levels had actually remained stable for decades), and then in the 1980s, during debates over the Free Trade Agreement.

But the situation has changed, since in the interim period Canada itself became a major investor and owner of foreign corporations. Since the 1980s, Canada’s levels of investment and ownership in foreign companies have been larger than foreign investment and ownership in Canada. In some smaller countries, such as Montenegro, Canadian investment is sizable enough to make up a major portion of the economy. In Northern Ireland, for example, Canada is the largest foreign investor. By becoming foreign owners themselves, Canadians have become far less politically concerned about investment within Canada.

Of note is that Canada’s largest companies by value, and largest employers, tend to be foreign-owned in a way that is more typical of a developing nation than a G8 member. The best example is the automotive sector, one of Canada’s most important industries. It is dominated by American, German, and Japanese giants. Although this situation is not unique to Canada in the global context, it is unique among G-8 nations, and many other relatively small nations also have national automotive companies.

It’s interesting to note that sometimes Canadian companies are the big investors but that doesn’t change our basic position. And, as I’ve noted in other postings (including the March 24, 2017 posting), these government investments in science and technology won’t necessarily lead to a move away from our ‘branch plant economy’ towards an innovative Canada.

You can find out more about the Vector Institute for Artificial Intelligence here.

BTW, I noted that reference to Hinton as ‘British-born’ in the BBC article. He was educated in the UK and subsidized by UK taxpayers (from his Wikipedia entry; Note: Links have been removed),

Hinton was educated at King’s College, Cambridge graduating in 1970, with a Bachelor of Arts in experimental psychology.[1] He continued his study at the University of Edinburgh where he was awarded a PhD in artificial intelligence in 1977 for research supervised by H. Christopher Longuet-Higgins.[3][12]

It seems Canadians are not the only ones to experience  ‘brain drains’.

Finally, I wrote at length about a recent initiative taking place between the University of British Columbia (Vancouver, Canada) and the University of Washington (Seattle, Washington), the Cascadia Urban Analytics Cooperative in a Feb. 28, 2017 posting noting that the initiative is being funded by Microsoft to the tune $1M and is part of a larger cooperative effort between the province of British Columbia and the state of Washington. Artificial intelligence is not the only area where US technology companies are hedging their bets (against Trump’s administration which seems determined to terrify people from crossing US borders) by investing in Canada.

For anyone interested in a little more information about AI in the US and China, there’s today’s (March 31, 2017)earlier posting: China, US, and the race for artificial intelligence research domination.

Brains, prostheses, nanotechnology, and human enhancement: summary (part five of five)

The Brain research, ethics, and nanotechnology (part one of five) May 19, 2014 post kicked off a series titled ‘Brains, prostheses, nanotechnology, and human enhancement’ which brings together a number of developments in the worlds of neuroscience, prosthetics, and, incidentally, nanotechnology in the field of interest called human enhancement. Parts one through four are an attempt to draw together a number of new developments, mostly in the US and in Europe. Due to my language skills which extend to English and, more tenuously, French, I can’t provide a more ‘global perspective’.

Now for the summary. Ranging from research meant to divulge more about how the brain operates in hopes of healing conditions such as Parkinson’s and Alzeheimer’s diseases to utilizing public engagement exercises (first developed for nanotechnology) for public education and acceptance of brain research to the development of prostheses for the nervous system such as the Walk Again robotic suit for individuals with paraplegia (and, I expect quadriplegia [aka tetraplegia] in the future), brain research is huge in terms of its impact socially and economically across the globe.

Until now, I have not included information about neuromorphic engineering (creating computers with the processing capabilities of human brains). My May 16, 2014 posting (Wacky oxide. biological synchronicity, and human brainlike computing) features one of the latest developments along with this paragraph providing links to overview materials of the field,

As noted earlier, there are other approaches to creating an artificial brain, i.e., neuromorphic engineering. My April 7, 2014 posting is the most recent synopsis posted here; it includes excerpts from a Nanowerk Spotlight article overview along with a mention of the ‘brain jelly’ approach and a discussion of my somewhat extensive coverage of memristors and a mention of work on nanoionic devices. There is also a published roadmap to neuromorphic engineering featuring both analog and digital devices, mentioned in my April 18, 2014 posting.

There is an international brain (artificial and organic) enterprise underway. Meanwhile, work understanding the brain will lead to new therapies and, inevitably, attempts to enhance intelligence. There are already drugs and magic potions (e.g. oxygenated water in Mental clarity, stamina, endurance — is it in the bottle? Celebrity athletes tout the benefits of oxygenated water, but scientists have their doubts, a May 16,2014 article by Pamela Fayerman for the Vancouver Sun). In a June 19, 2009 posting featured Jamais Cascio’s  speculations about augmenting intelligence in an Atlantic magazine article.

While researchers such Miguel Nicolelis work on exoskeletons (externally worn robotic suits) controlled by the wearer’s thoughts and giving individuals with paraplegia the ability to walk, researchers from one of Germany’s Fraunhofer Institutes reveal a different technology for achieving the same ends. From a May 16, 2014 news item on Nanowerk,

People with severe injuries to their spinal cord currently have no prospect of recovery and remain confined to their wheelchairs. Now, all that could change with a new treatment that stimulates the spinal cord using electric impulses. The hope is that the technique will help paraplegic patients learn to walk again. From June 3 – 5 [2-14], Fraunhofer researchers will be at the Sensor + Test measurement fair in Nürnberg to showcase the implantable microelectrode sensors they have developed in the course of pre-clinical development work (Hall 12, Booth 12-537).

A May 14, 2014 Fraunhofer Institute news release, which originated the news item, provides more details about this technology along with an image of the implantable microelectrode sensors,

The implantable microelectrode sensors are flexible and wafer-thin. © Fraunhofer IMM

The implantable microelectrode sensors are flexible and wafer-thin.
© Fraunhofer IMM

Now a consortium of European research institutions and companies want to get affected patients quite literally back on their feet. In the EU’s [European Union’s] NEUWalk project, which has been awarded funding of some nine million euros, researchers are working on a new method of treatment designed to restore motor function in patients who have suffered severe injuries to their spinal cord. The technique relies on electrically stimulating the nerve pathways in the spinal cord. “In the injured area, the nerve cells have been damaged to such an extent that they no longer receive usable information from the brain, so the stimulation needs to be delivered beneath that,” explains Dr. Peter Detemple, head of department at the Fraunhofer Institute for Chemical Technology’s Mainz branch (IMM) and NEUWalk project coordinator. To do this, Detemple and his team are developing flexible, wafer-thin microelectrodes that are implanted within the spinal canal on the spinal cord. These multichannel electrode arrays stimulate the nerve pathways with electric impulses that are generated by the accompanying by microprocessor-controlled neurostimulator. “The various electrodes of the array are located around the nerve roots responsible for locomotion. By delivering a series of pulses, we can trigger those nerve roots in the correct order to provoke motion sequences of movements and support the motor function,” says Detemple.

Researchers from the consortium have already successfully conducted tests on rats in which the spinal cord had not been completely severed. As well as stimulating the spinal cord, the rats were given a combination of medicine and rehabilitation training. Afterwards the animals were able not only to walk but also to run, climb stairs and surmount obstacles. “We were able to trigger specific movements by delivering certain sequences of pulses to the various electrodes implanted on the spinal cord,” says Detemple. The research scientist and his team believe that the same approach could help people to walk again, too. “We hope that we will be able to transfer the results of our animal testing to people. Of course, people who have suffered injuries to their spinal cord will still be limited when it comes to sport or walking long distances. The first priority is to give them a certain level of independence so that they can move around their apartment and look after themselves, for instance, or walk for short distances without requiring assistance,” says Detemple.

Researchers from the NEUWalk project intend to try out their system on two patients this summer. In this case, the patients are not completely paraplegic, which means there is still some limited communication between the brain and the legs. The scientists are currently working on tailored implants for the intervention. “However, even if both trials are a success, it will still be a few years before the system is ready for the general market. First, the method has to undergo clinical studies and demonstrate its effectiveness among a wider group of patients,” says Detemple.

Patients with Parkinson’s disease could also benefit from the neural prostheses. The most well-known symptoms of the disease are trembling, extreme muscle tremors and a short, [emphasis mine] stooped gait that has a profound effect on patients’ mobility. Until now this neurodegenerative disorder has mostly been treated with dopamine agonists – drugs that chemically imitate the effects of dopamine but that often lead to severe side effects when taken over a longer period of time. Once the disease has reached an advanced stage, doctors often turn to deep brain stimulation. This involves a complex operation to implant electrodes in specific parts of the brain so that the nerve cells in the region can be stimulated or suppressed as required. In the NEUWalk project, researchers are working on electric spinal cord simulation – an altogether less dangerous intervention that should however ease the symptoms of Parkinson’s disease just as effectively. “Initial animal testing has yielded some very promising results,” says Detemple.

(For anyone interested in the NEUWalk project, you can find more here,) Note the reference to Parkinson’s in the context of work designed for people with paraplegia. Brain research and prosthetics (specifically neuroprosthetics or neural prosthetics), are interconnected. As for the nanotechnology connection, in its role as an enabling technology it has provided some of the tools that make these efforts possible. It has also made some of the work in neuromorphic engineering (attempts to create an artificial brain that mimics the human brain) possible. It is a given that research on the human brain will inform efforts in neuromorphic engineering and that attempts will be made to create prostheses for the brain (cyborg brain) and other enhancements.

One final comment, I’m not so sure that transferring approaches and techniques developed to gain public acceptance of nanotechnology are necessarily going to be effective. (Harthorn seemed to be suggesting in her presentation to the Presidential Presidential Commission for the Study of Bioethical Issues that these ‘nano’ approaches could be adopted. Other researchers [Caulfield with the genome and Racine with previous neuroscience efforts] also suggested their experience could be transferred. While some of that is likely true,, it should be noted that some self-interest may be involved as brain research is likely to be a fresh source of funding for social science researchers with experience in nanotechnology and genomics who may be finding their usual funding sources less generous than previously.)

The likelihood there will be a substantive public panic over brain research is higher than it ever was for a nanotechnology panic (I am speaking with the benefit of hindsight re: nano panics). Everyone understands the word, ‘brain’, far fewer understand the word ‘nanotechnology’ which means that the level of interest is lower and people are less likely to get disturbed by an obscure technology. (The GMO panic gained serious traction with the ‘Frankenfood’ branding and when it fused rather unexpectedly with another research story,  stem cell research. In the UK, one can also add the panic over ‘mad cow’ disease or Creutzfeldt-Jakob disease (CJD), as it’s also known, to the mix. It was the GMO and other assorted panics which provided the impetus for much of the public engagement funding for nanotechnology.)

All one has to do in this instance is start discussions about changing someone’s brain and cyborgs and these researchers may find they have a much more volatile situation on their hands. As well, everyone (the general public and civil society groups/activists, not just the social science and science researchers) involved in the nanotechnology public engagement exercises has learned from the experience. In the meantime, pop culture concerns itself with zombies and we all know what they like to eat.

Links to other posts in the Brains, prostheses, nanotechnology, and human enhancement five-part series

Part one: Brain research, ethics, and nanotechnology (May 19, 2014 post)

Part two: BRAIN and ethics in the US with some Canucks (not the hockey team) participating (May 19, 2014)

Part three: Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society issued May 2014 by US Presidential Bioethics Commission (May 20, 2014)

Part four: Brazil, the 2014 World Cup kickoff, and a mind-controlled exoskeleton (May 20, 2014)

BRAIN and ethics in the US with some Canucks (not the hockey team) participating (part two of five)

The Brain research, ethics, and nanotechnology (part one of five) May 19, 2014 post kicked off a series titled ‘Brains, prostheses, nanotechnology, and human enhancement’ which brings together a number of developments in the worlds of neuroscience*, prosthetics, and, incidentally, nanotechnology in the field of interest called human enhancement. Parts one through four are an attempt to draw together a number of new developments, mostly in the US and in Europe. Due to my language skills which extend to English and, more tenuously, French, I can’t provide a more ‘global perspective’. Part five features a summary.

Before further discussing the US Presidential Commission for the Study of Bioethical Issues ‘brain’ meetings mentioned in part one, I have some background information.

The US launched its self-explanatory BRAIN (Brain Research through Advancing Innovative Neurotechnologies) initiative (originally called BAM; Brain Activity Map) in 2013. (You can find more about the history and details in this Wikipedia entry.)

From the beginning there has been discussion about how nanotechnology will be of fundamental use in the US BRAIN initiative and the European Union’s 10 year Human Brain Project (there’s more about that in my Jan. 28, 2013 posting). There’s also a 2013 book (Nanotechnology, the Brain, and the Future) from Springer, which, according to the table of contents, presents an exciting (to me) range of ideas about nanotechnology and brain research,

I. Introduction and key resources

1. Nanotechnology, the brain, and the future: Anticipatory governance via end-to-end real-time technology assessment by Jason Scott Robert, Ira Bennett, and Clark A. Miller
2. The complex cognitive systems manifesto by Richard P. W. Loosemore
3. Analysis of bibliometric data for research at the intersection of nanotechnology and neuroscience by Christina Nulle, Clark A. Miller, Harmeet Singh, and Alan Porter
4. Public attitudes toward nanotechnology-enabled human enhancement in the United States by Sean Hays, Michael Cobb, and Clark A. Miller
5. U.S. news coverage of neuroscience nanotechnology: How U.S. newspapers have covered neuroscience nanotechnology during the last decade by Doo-Hun Choi, Anthony Dudo, and Dietram Scheufele
6. Nanoethics and the brain by Valerye Milleson
7. Nanotechnology and religion: A dialogue by Tobie Milford

II. Brain repair

8. The age of neuroelectronics by Adam Keiper
9. Cochlear implants and Deaf culture by Derrick Anderson
10. Healing the blind: Attitudes of blind people toward technologies to cure blindness by Arielle Silverman
11. Ethical, legal and social aspects of brain-implants using nano-scale materials and techniques by Francois Berger et al.
12. Nanotechnology, the brain, and personal identity by Stephanie Naufel

III. Brain enhancement

13. Narratives of intelligence: the sociotechnical context of cognitive enhancement by Sean Hays
14. Towards responsible use of cognitive-enhancing drugs by the healthy by Henry T. Greeley et al.
15. The opposite of human enhancement: Nanotechnology and the blind chicken debate by Paul B. Thompson
16. Anticipatory governance of human enhancement: The National Citizens’ Technology Forum by Patrick Hamlett, Michael Cobb, and David Guston
a. Arizona site report
b. California site report
c. Colorado site reportd. Georgia site report
e. New Hampshire site report
f. Wisconsin site report

IV. Brain damage

17. A review of nanoparticle functionality and toxicity on the central nervous system by Yang et al.
18. Recommendations for a municipal health and safety policy for nanomaterials: A Report to the City of Cambridge City Manager by Sam Lipson
19. Museum of Science Nanotechnology Forum lets participants be the judge by Mark Griffin
20. Nanotechnology policy and citizen engagement in Cambridge, Massachusetts: Local reflexive governance by Shannon Conley

Thanks to David Bruggeman’s May 13, 2014 posting on his Pasco Phronesis blog, I stumbled across both a future meeting notice and documentation of the  Feb. 2014 meeting of the Presidential Commission for the Study of Bioethical Issues (Note: Links have been removed),

Continuing from its last meeting (in February 2014), the Presidential Commission for the Study of Bioethical Issues will continue working on the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative in its June 9-10 meeting in Atlanta, Georgia.  An agenda is still forthcoming, …

In other developments, Commission staff are apparently going to examine some efforts to engage bioethical issues through plays.  I’d be very excited to see some of this happen during a Commission meeting, but any little bit is interesting.  The authors of these plays, Karen H. Rothenburg and Lynn W. Bush, have published excerpts in their book The Drama of DNA: Narrative Genomics.  …

The Commission also has a YouTube channel …

Integrating a theatrical experience into the reams of public engagement exercises that technologies such as stem cell, GMO (genetically modified organisms), nanotechnology, etc. tend to spawn seems a delightful idea.

Interestingly, the meeting in June 2014 will coincide with the book’s release date. I dug further and found these snippets of information. The book is being published by Oxford University Press and is available in both paperback and e-book formats. The authors are not playwrights, as one might assume. From the Author Information page,

Lynn Bush, PhD, MS, MA is on the faculty of Pediatric Clinical Genetics at Columbia University Medical Center, a faculty associate at their Center for Bioethics, and serves as an ethicist on pediatric and genomic advisory committees for numerous academic medical centers and professional organizations. Dr. Bush has an interdisciplinary graduate background in clinical and developmental psychology, bioethics, genomics, public health, and neuroscience that informs her research, writing, and teaching on the ethical, psychological, and policy challenges of genomic medicine and clinical research with children, and prenatal-newborn screening and sequencing.

Karen H. Rothenberg, JD, MPA serves as Senior Advisor on Genomics and Society to the Director, National Human Genome Research Institute and Visiting Scholar, Department of Bioethics, Clinical Center, National Institutes of Health. She is the Marjorie Cook Professor of Law, Founding Director, Law & Health Care Program and former Dean at the University of Maryland Francis King Carey School of Law and Visiting Professor, Johns Hopkins Berman Institute of Bioethics. Professor Rothenberg has served as Chair of the Maryland Stem Cell Research Commission, President of the American Society of Law, Medicine and Ethics, and has been on many NIH expert committees, including the NIH Recombinant DNA Advisory Committee.

It is possible to get a table of contents for the book but I notice not a single playwright is mentioned in any of the promotional material for the book. While I like the idea in principle, it seems a bit odd and suggests that these are purpose-written plays. I have not had good experiences with purpose-written plays which tend to be didactic and dull, especially when they’re not devised by a professional storyteller.

You can find out more about the upcoming ‘bioethics’ June 9 – 10, 2014 meeting here.  As for the Feb. 10 – 11, 2014 meeting, the Brain research, ethics, and nanotechnology (part one of five) May 19, 2014 post featured Barbara Herr Harthorn’s (director of the Center for Nanotechnology in Society at the University of California at Santa Barbara) participation only.

It turns out, there are some Canadian tidbits. From the Meeting Sixteen: Feb. 10-11, 2014 webcasts page, (each presenter is featured in their own webcast of approximately 11 mins.)

Timothy Caulfield, LL.M., F.R.S.C., F.C.A.H.S.

Canada Research Chair in Health Law and Policy
Professor in the Faculty of Law
and the School of Public Health
University of Alberta

Eric Racine, Ph.D.

Director, Neuroethics Research Unit
Associate Research Professor
Institut de Recherches Cliniques de Montréal
Associate Research Professor,
Department of Medicine
Université de Montréal
Adjunct Professor, Department of Medicine and Department of Neurology and Neurosurgery,
McGill University

It was a surprise to see a couple of Canucks listed as presenters and I’m grateful that the Presidential Commission for the Study of Bioethical Issues is so generous with information. in addition to the webcasts, there is the Federal Register Notice of the meeting, an agenda, transcripts, and presentation materials. By the way, Caulfield discussed hype and Racine discussed public understanding of science with regard to neuroscience both fitting into the overall theme of communication. I’ll have to look more thoroughly but it seems to me there’s no mention of pop culture as a means of communicating about science and technology.

Links to other posts in the Brains, prostheses, nanotechnology, and human enhancement five-part series:

Part one: Brain research, ethics, and nanotechnology (May 19, 2014 post)

Part three: Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society issued May 2014 by US Presidential Bioethics Commission (May 20, 2014)

Part four: Brazil, the 2014 World Cup kickoff, and a mind-controlled exoskeleton (May 20, 2014)

Part five: Brains, prostheses, nanotechnology, and human enhancement: summary (May 20, 2014)

* ‘neursocience’ corrected to ‘neuroscience’ on May 20, 2014.

Canada, emerging technologies, and chemical assessments (pesticides)

The Council of Canadian Academies released a report titled, Integrating Emerging Technologies into Chemical Safety Assessment, on Jan. 12, 2012. It wasn’t what I thought it might be.

Before launching into the report, it might be helpful to know something more about the Council of Canadian Academies. (Shockingly, I can’t find a description of the group in the postings where I’ve mentioned them previously.) From the Council’s About Us page (Mar.23.12 Note: I have removed links to the Council’s Board of Governors, etc.),

The Council is an independent, not-for-profit corporation that supports science-based, expert assessments (studies) to inform public policy development in Canada. The Council began operation in 2005 and consists of a Board of Governors,  a Scientific Advisory Committee and Secretariat. The Council draws upon the intellectual capital that lies within its three Member Academies the Royal Society of Canada (RSC); the Canadian Academy of Engineering; and the Canadian Academy of Health Sciences.

Our mission is to contribute to the shaping of evidence-based public policy that is in the public interest. This is achieved by appointing independent, multidisciplinary panels of expert volunteers. The Council’s work encompasses a broad definition of science, incorporating the natural, social and health sciences as well as engineering and the humanities.

This latest report on emerging technologies and chemical assessments is in fact a report on emerging technologies for  health and safety assessment procedures of toxic chemicals using pesticides as a test case. Here’s the reasoning (from the abridged version of the report, Report in Focus; Integrating Emerging Technologies into Chemical Safety Assessment),

Protecting human health and the environment is of paramount importance to Canadians. As such, there has been an increasing demand for improved regulation of chemicals in Canada. Nevertheless, recent estimates suggest that toxicity data are lacking for over three quarters of the chemicals on the market. In fact, this paucity of data can extend to the other components within a chemical product. For example, the active ingredients in pesticides are among the most stringently regulated compounds on the market; however, the final pesticide product may also contain data-poor formulants. Added to enhance the use or increase the stability of the pesticide product, formulants are not typically subjected to the full battery of toxicity tests that the active ingredients must undergo.

The data-rich and data-poor nature of pesticide formulation is a metaphor for the dichotomy that exists for most industrial chemicals. While there are some substances for which we have an enormous amount of data, such as pesticide active ingredients, the vast majority of industrial chemicals are extremely data-poor. (p. 1)

This specific report was commissioned by the Minister of Health. From the Report in Focus; Integrating Emerging Technologies into Chemical Safety Assessment,

All levels of government in Canada play a role in regulating the sale and use of pesticides; however, the federal government is responsible for the registration of pest control products in Canada. In May 2009, the Minister of Health, on behalf of the Pest Management Regulatory Agency (PMRA), approached the Council of Canadian Academies to appoint an expert panel to answer the question:

“What is the scientific status of the use of integrated testing strategies in the human and environmental regulatory risk assessment of pesticides.”

In response to this question, the Council assembled a multidisciplinary panel of 15 eminent experts from Canada and the United States. (p. 3)

Here’s a list of the members of the Expert Panel (from the Executive Summary; Integrating Emerging Technologies into Chemical Safety Assessment),

The Expert Panel on the Integrated Testing of Pesticides

Leonard Ritter (Chair) Executive Director, Canadian Network of Toxicology Centres; and Professor of Toxicology, University of Guelph (Guelph, ON)

Christopher P. Austin Director, Chemical Genomics Center, National Institutes of Health (Bethesda, MD)

John R. (Jack) Bend Distinguished University Professor, Departments of Pathology; Physiology and Pharmacology; and Paediatrics in the Schulich School of Medicine and Dentistry, University of Western Ontario (London, ON)

Conrad G. Brunk Professor of Philosophy, University of Victoria (Victoria, BC)

Timothy Caulfield, FRSC, FCAHS Professor, Faculty of Law and School of Public Health; Research Director, Health Law Institute; and Canada Research Chair in Health Law and Policy, University of Alberta (Edmonton, AB)

Vicki L. Dellarco Science Advisor, Office of Pesticide Programs, United States Environmental Protection Agency (Washington, DC)

Paul A. Demers Director, School of Environmental Health, College for Interdisciplinary Studies; and Professor, School of Population & Public Health, Faculty of Medicine, University of British Columbia (Vancouver, BC)

Warren Foster Professor, Department of Obstetrics and Gynaecology; and Director, Centre for Reproductive Care, McMaster University Health Sciences Centre (Hamilton, ON)

Claire Infante-Rivard Professor, Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University (Montréal, QC)

Catherine Jumarie Professor, Department of Biological Sciences, Université du Québec à Montréal (Montréal, QC)

Sam Kacew Associate Director of Toxicology, R. Samuel McLaughlin Centre for Population Health Risk Assessment, Institute of Population Health, University of Ottawa (Ottawa, ON)

Robert J. Kavlock Director, National Center for Computational Toxicology, United States Environmental Protection Agency (Durham, NC)

Daniel Krewski Director, R. Samuel McLaughlin Centre for Population Health Risk Assessment, Institute of Population Health, University of Ottawa (Ottawa, ON)

Paul G. Mezey Canada Research Chair in Scientific Modelling and Simulation, Memorial University of Newfoundland (St. John’s, NL)

Terry W. Schultz Emeritus Professor, Department of Comparative Medicine, College of Veterinary Medicine, University of Tennessee (Knoxville, TN) (p. 7)

Getting to the point (from the Executive Summary),

“The issues inherent in the current approach to chemical testing are two-fold: to address the lack of toxicity data for the vast majority of industrial chemicals and to recognize that regulatory decisions must be based on the best available science. The Panel believes that these challenges can be best met by adopting an Integrated Approach to Testing and Assessment (IATA).” – Leonard Ritter, Chair of the Expert Panel (p. 4)

As for what that means,

Integrated Approaches to Testing and Assessment (IATA) represent a pragmatic approach that will move toxicology away from describing what happens towards an explanation of how it happens. Toxicity testing will no longer depend on the one-size-fits-all hazard-based checklist of tests currently used but rather be based on a refined and focused testing strategy tailored to the toxicity profile and intended use of the chemical in question. An IATA strategy uses a tiered approach to help categorize and prioritize higher risk chemicals; all of the existing data on a substance are compiled at the start of the testing process in order to evaluate what data gaps exist and what testing approaches would be most appropriate to understand the precise toxicological profile of that substance.

Given my interest in the toxicological impacts of nanomaterials and concerns about responding to uncertainty and risk in a timely and appropriate fashion, this approach seems promising. Of course, the recommendations may or may not be accepted and, even then, there’s no telling what implementation would look like. Still, I am encouraged.

You can find a full list of all the documents (Report, Report in Focus, Executive Summary, etc.) here.