Category Archives: Pharma

Alzheimer’s disease – not cracking the nut (yet)

As an anthropologist, market researcher and consultant working with pharmaceutical companies, I follow trends in the medical field. Neuroscience is one of the areas on the rise. Expecting this field to accelerate in terms of drug development, I compiled a comprehensive database of Canadian neurologists and started engaging this audience. Alzheimer’s disease specifically is an area of great unmet need where a massive market is ripe for innovations, pharmacological and otherwise. I recently surveyed neurologists to better understand their perspectives. You can read the results here: https://creativeresearchdesigns.com/examples-of-work

Neuroscience has received significant investment in the past decade.

In the U.S., President Obama launched the Brain Initiative in 2013 with a $100 million US dollar investment. He said: “Today, our scientists are mapping the human brain to unlock the answers to Alzheimer’s… Now is not the time to gut these job-creating investments in science and innovation. Now is the time to reach a level of research and development not seen since the height of the Space Race.”1

A similar investment was made in Canada with the establishment of the Brain Research Fund in 2011, a public-private partnership between Brain Canada and Health Canada. Its website describes the purpose of the investment as follows: “This visionary commitment by the federal government will ensure that Canada continues to be among the leaders in the global challenge to understand brain function and brain diseases.”2 Regional and local initiatives abound.3

However, while research funding is available, many worthwhile initiatives are competing for it.

Brain science is a diverse field; and neurologists often specialize in a particular area.

When I researched Canadian neurologists and potential participants for my Alzheimer’s survey, I noticed that only a subset of neurologists deals with Alzheimer’s and other dementias. Other significant specializations include multiple sclerosis, epilepsy, neuromuscular disorders, movement disorders (incl. Parkinson’s), migraine/ headache and stroke. The patient populations affected by these conditions are quite diverse, with epilepsy, MS, and migraine often affecting younger individuals and dementia, Parkinson’s and stroke primarily being diseases of the elderly.

While there are currently just over a thousand neurologists in Canada,4 only a subset of these would be relevant to a pharmaceutical company marketing a specific neurology drug.   

Many pharmaceutical companies have ventured into the area of neuroscience. According to the website Statistica, the top selling neurological drug products (2016 in the U.S.) are multiple sclerosis treatments, followed by medications for schizophrenia and bipolar disorder.5 Disease onset is typically younger for these conditions, impairment of day-to-day functioning can be significant, and patients remain on treatment for decades. Thus, they present interesting opportunities for pharmaceutical development.

Alzheimer’s disease is overdue for breakthrough discoveries.

But neurological diseases of the elderly have also received significant attention. Alzheimer’s disease, in particular, has proven to be a hard nut to crack. The last new treatment (Ebixa/memantine) came to Canada in 2005, joining the three cholinesterase inhibitors Aricept (donepezil), Exelon (rivastigmine) and Reminyl (galantamine). Neither of these agents are particularly effective in slowing down the progression of the disease. 

Many companies have tried to tackle the challenge of Alzheimer’s disease. Up until now, the path to a brighter future has been littered with unsuccessful clinical trials.6 Just this year, another five major flops joined the long list of previous attempts: Roche/AC Immune’s anti-tau antibody semorinemab, AbbVie/Voyager Therapeutics’ gene therapies, Sanofi/Denali’s RIPK1 inhibitor DNL747, and Eli Lilly’s and Roche’s amyloid antibodies solanezumab and gantenerumab. Biogen’s monoclonal antibody aducanumab is still in the running, but it faces an uphill battle to secure approval.

Will large pharma turn away, and leave the field to small, pre-clinical research companies for the time being? I believe there is reason for optimism about the future of brain research and the development of Alzheimer’s drugs specifically. Public attention and government incentives will continue to stimulate research. According to a recent article, 121 agents were in clinical trials for the treatment of Alzheimer’s disease at the beginning of 2020 (in ClinicalTrials.gov).7 Some are sponsored by large pharma and some by small start-ups. Even if beta-amyloid and tau protein turn out to be less promising drug targets than previously thought, with continued investment in this field, scientists are bound to come up with something eventually.

Non-pharmacological interventions deserve attention in Alzheimer’s.

In my survey among Canadian neurologists, one of the results that I found most interesting was their recognition of the importance of non-pharmacological measures.

Unprompted, Canadian neurologists identified supporting families, caregivers and home care as one of the top investment priorities to improve the lives of people with Alzheimer’s. When presented with a list of possible investment priorities, neurologists again picked ‘improved funding for home care’ along with ‘research into new drug treatments’ as the top two. Increased funding for long-term care facilities was perceived as less important.

Staying at home is certainly preferrable to living in long-term care, particularly under the current circumstances of the pandemic, and specific non-pharmacological interventions have the potential to significantly increase quality of life for Alzheimer’s patients.

One finding that intrigues and delights me is the brain’s storage of musical memories and the effect of music on the brain. It has been shown that memories of music persist while names of loved ones may already be fading into the background. The stimulation of those memories, and the participation in the making of music, can fill those affected by Alzheimer’s with great joy.

One of the projects supported by the Alzheimer’s Society of Canada is Voices in Motion, an intergenerational choir that brings together people with Alzheimer’s disease, caregivers and high school students.8 It combines the joyful act of singing with physical movement and social interaction. Based on findings from this study, researcher Dr. Debra Sheets, Associate Professor in the School of Nursing in Victoria, BC, will create a toolkit of best practices that can be used by other organizations who are interested in starting a community choir for people with dementia.

Early detection and screening are important, and AI may have a role to play in it.

For Alzheimer’s disease as well as for other areas of health, accurate and early diagnosis plays an important role in halting or slowing the disease before its effects become devastating. In fact, when my survey asked about top investment priorities, neurologists mentioned early detection and prevention unprompted. While there has been considerable research into biomarkers and brain imaging technology, more recently a number of companies have tried to harness the power of artificial intelligence for early detection of Alzheimer’s disease.

The Toronto startup Winterlight Labs uses AI to analyze speech patterns to detect cognitive impairment and other brain disorders.9 The company built a tablet-based assessment tool that is already being used in a clinical trial for an Alzheimer’s drug. Tech industry giant IBM, in conjunction with Pfizer, is working on something similar that presumably can predict onset of Alzheimer’s with 71% accuracy.10 Researchers at the Boston School of Medicine have developed a computer algorithm based on AI that can accurately predict the risk for and diagnose Alzheimer’s disease using a combination of MRI, testing to measure cognitive impairment, and data on age and gender.11

In Conclusion

Brain health is responsive to a variety of behavioural, technological and pharmacological interventions. Hopefully, research investments in Alzheimer’s will pay off in the not-so-distant future, and lead to breakthroughs that significantly improve the trajectory of this disease and the quality of life of those affected. I am keeping my fingers crossed.

1: https://obamawhitehouse.archives.gov/BRAIN; https://obamawhitehouse.archives.gov/the-press-office/2013/04/02/fact-sheet-brain-initiative

2: https://braincanada.ca/canada-brain-research-fund/

3: https://blog.braininstitute.ca/mental-health-is-brain-health-a-paradigm-shift/; http://www.camh.ca/en/driving-change/about-camh; https://www.uhn.ca/KNC; https://www.baycrest.org/; https://blog.mtl.org/en/montreal-leads-way-neuroscience-breakthroughs; https://www.mcgill.ca/neuro/

4: https://www.cma.ca/sites/default/files/pdf/Physician%20Data/01-physicians-by-specialty-province-e.pdf

5: https://www.statista.com/statistics/318259/revenue-of-top-20-neurology-products-in-the-us/

6: List of recently failed clinical trials in Alzheimer’s disease

Roche/AC Immune: https://www.fiercebiotech.com/biotech/roche-ac-immune-s-tau-blocking-drug-flops-alzheimer-s-as-biotech-s-shares-halved

AbbVie/Voyager Therapeutics: https://www.fiercebiotech.com/biotech/abbvie-cans-voyager-alzheimer-s-parkinson-s-gene-therapy-pacts

Sanofi/Denali: https://www.biospace.com/article/denali-and-sanofi-pause-alzheimer-s-trial-and-pivot-to-another-drug/

Eli Lilly and Roche: https://www.fiercebiotech.com/biotech/lilly-and-roche-s-antibodies-fail-late-phase-alzheimer-s-test

7: https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.12050

8: http://alzheimersocietyblog.ca/meet-researchers-debra-sheets-university-of-victoria/

9: https://winterlightlabs.com/

10: https://venturebeat.com/2020/10/22/ibm-and-pfizer-claim-ai-can-predict-alzheimers-onset-with-71-accuracy/

11: https://neurosciencenews.com/ai-alzheimers-16326/

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Medical marijuana in Canada

I attended a very interesting Life Sciences Ontario (LSO) breakfast meeting on medical marijuana in Canada. Here are some key takeaways:

Production

  • Currently there are only 38 licensed producers (LPs) in Canada that grow the plant.
  • Regulators control access to this market tightly and barriers for new companies to become licensed producers are high.
  • One of the challenges for production is to grow a standardized crop, i.e. plants that have roughly the same level of chemical compounds in them crop after crop.
  • Canada is perceived as one of the top players worldwide for growing of marijuana under controlled conditions that will stand up to health regulators’ scrutiny (along with Israel).

Distribution

  • Dispensaries are illegal – there is no legal grey zone. It is not Health Canada’s job to monitor dispensaries. This is the responsibility of municipalities. There seem to be crack downs on dispensaries occasionally, but then they spring up again.
  • The only legal way to obtain medical marijuana in Canada is through licensed producers, and they will ship the product to the patient directly.
  • There is currently a push to make other forms of distribution legal. At the forefront of this is Shoppers Drug Mart’s effort to convince regulators to let them dispense the product at their pharmacies. So far, no luck.

Acceptance in physician practice and among patients

  • Clinical studies on the benefits of medical marijuana are challenging since it is difficult to grow a stable product that will have the same properties throughout the course of the trial. Getting clinical studies published in peer-reviewed journals is also challenging. However, audience members felt that Canada is in an advantageous position in terms of conducting more research in this area.
  • The Canadian Medical Association does not condone widespread prescribing of medical marijuana, but it also does not actively deter physicians.
  • One of the challenges for physicians in prescribing medical marijuana is the fact that the product comes in a variety of forms and may not be stable/standardized. Many are uncomfortable prescribing the dry form, since it is unclear how exactly to dose it for a given patient. Prescribing the oil may be easier for physicians.
  • Patients may also have different preferences for an oil vs an inhaled product or even an edible.

Taxation

  • Experience in the U.S. has shown that the market will be impacted by decisions on taxation. If, for example, medical marijuana is taxed heavily and the recreational use of the product is taxed more lightly, patients will tend not to bother getting a prescription.

Regulatory

  • The regulatory process is moving slowly, slowly. While a regulatory framework has recently been proposed, making it into law could take 18 months or longer. According to meeting participants, the proposed framework will likely undergo many changes, and a final decision is not expected before 2019.

The LSO breakfast meeting took place on January 19, 2017 at the offices of Fasken Martineau in Toronto. The meeting was chaired by LSO Board member Dr. Alison Symington. The panelists were:

Ken Clement, CEO of ABcann Medicinals Inc, a licensed producer of medical marijuana. ABcann’s business is focused on growing organic standardized medical cannabis, recognizing that an expertise in growing standardized crops positions the company well in the medical marijuana market.

Christelle Gedeon, Associate at Fasken Martineau DuMoulin, is one of the firm’s regulatory affairs specialists with expertise in pharmaceuticals, medical devices, natural health products and medical marijuana, among other things.

Nick Antoniadis, Principal at Nick Antoniadis Consulting, is owner of his Toronto-based management consulting company. He is a marketing leader with over 20-years-experience in global healthcare. In the medical marijuana market, he has focused on connecting with and gaining insights from patient aggregators such as prescribing physicians.

Summary prepared by Barbara McGrath, PhD, Owner of Creative Research Designs, a company that provides customer insight and market research to companies in healthcare. This summary was not reviewed by LSO or any of the meeting participants. It reflects my own understanding of what was being said. You can contact me at: barbara@creativeresearchdesigns.com

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Doing Business on a Global Scale

Today, it was reported that “Chinese court finds GlaxoSmithKline guilty of bribery”. This raises the question: Is the Chinese government really cleaning up? Or did they just not bribe the right people? Why is GSK in the spotlight and not others?

Having lived and worked in Russia, and frequently discussing their country’s state of affairs with friends from Columbia, Iran, China and India*, bribery and favouritism seems to be a fact of life in a number of countries including BRIC and the Middle East.

Most people here in Canada and presumably also in the US would agree that bribery is bad. In fact, the US has very strict laws forbidding US businesses to engage in such practices abroad. I agree that one should uphold one’s moral standards in contexts which challenge them.

But I’d like to add a word or two to explain why bribery is so rampant in some countries. It is not a lack of business ethics, as one might suspect, but rather a reaction to the conditions under which businesses have to operate in these countries. What is really lacking there is the rule of law.

For someone who has lived in the ‘West’ all their lives, it is difficult to image what the absence of rule of law looks like, and what it does to you. Imagine business where you sign contracts but you cannot enforce them. Where you accumulate wealth, but where it can be taken from you at any time. Where you apply to the authorities – police, judges, lawmakers – for help, but they do not serve you. All and everything you do, your success and failure is dependent upon knowing the right people, forging the right alliances, and often money changes hands. If you run a profitable business, others want a piece of the pie, or they won’t let you do your work.

If you make the wrong move, if you get in the way of someone more powerful than you, then you go down – accused of bribery, tax fraud, unsanitary working conditions etc. etc. Maybe you are guilty, maybe you are not. If you are lucky, you can pay your way out of it. Otherwise, you may end up in jail like Mr. Khodorkovsky, or worse.

Yes, people pay bribes and they should not be doing that. Yes, people defraud on their taxes and they should not be doing that. Yes, people let their employees work in unhealthy and unsafe conditions and they should not be doing that.

However, those that get singled out and publicly blamed for their wrongdoing are not necessarily the worst culprits. They are simply the ones who did not play their cards right, who ticked someone off. So how did Glaxo get into this mess?

* Thanks to Toronto’s multicultural community!

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