When Michael Mallinson saw the results of the focus-group project that his small patient-advocacy organization had agreed to participate in, he was so disturbed he wanted to withdraw from the effort.
It was March of 2017 and Mr. Mallinson, then the president of a group representing Canadians with a little-known type of arthritis that affects the spine, was being asked to sign off on a report that found patients were “strongly opposed” to switching from their brand-name drug to a cheaper near-copy called a biosimilar.
That conclusion aligned neatly with the viewpoints of Janssen and AbbVie, the pharmaceutical companies with the most to lose from biosimilar competition. Their Canadian divisions paid for the report.
“Frankly,” Mr. Mallinson wrote in an e-mail to his board, “I am feeling uncomfortable and manipulated … if we withdraw, I think we will have a clearer conscience about not being conflicted with the positions of AbbVie and Janssen.”
When the board members agreed to take the group’s name off the report, they were biting the hands that fed their organization. The year before, 90 per cent of the Canadian Spondylitis Association’s budget had come from AbbVie and Janssen.
According to Mr. Mallinson, a Janssen employee threatened to stop funding the spondylitis group after it pulled out of the project; Janssen, through a spokeswoman, said Mr. Mallinson’s “characterization of that discussion was not accurate.” Either way, Janssen rejected the spondylitis group’s requests for funding in 2017 and 2018.
The Canadian Spondylitis Association’s falling out with Janssen provides a rare glimpse into how some pharmaceutical companies try to press patient-advocacy groups whose influence can shape public opinion and policy in ways favourable to their drugs. (AbbVie, meanwhile, continued to fund the organization.)
Canada has at least 172 active patient-advocacy groups, ranging in size from prominent national charities to small, volunteer-led, disease groups that rely heavily on grants from drug makers. It’s a state of affairs that leaves pharma-funded patient organizations struggling to avoid conflicts of interest, while the few patient groups that refuse the money struggle to make their voices heard at all.
"That skews the whole system,” said Sharon Batt, a bioethics professor at Dalhousie University and the author of a book about how drug-company money changed the breast-cancer movement. “You’re hearing from one segment of the patient population and not the others because the others have nowhere to go for money.”
Drug-company courting of patient-advocacy groups has been especially vigorous on the biosimilar front, as The Globe and Mail learned during an investigation of Janssen’s Remicade, a medication for autoimmune disorders that remains the top-selling drug by revenue in Canada – even though it is the first blockbuster biologic to lose its patent and face competition from a biosimilar rival. A biologic is a drug manufactured from living cells.
Biosimilars are the not-quite-generic versions of biologic drugs. Produced from lab-altered cell lines rather than synthesized from chemicals, biologics are impossible to replicate perfectly. Health Canada, the U.S. Food and Drug Administration and the European Medicines Agency all say biosimilars are safe and effective, yet, in Canada, they’ve made barely a dent in the sales of the more expensive original biologics they mimic.
For the makers of biologics, the financial stakes are massive: Janssen sold more than $1.1-billion of Remicade in Canada last year, while AbbVie sold $738-million worth of its still-on-patent biologic for autoimmune disorders, Humira, according to the pharmaceutical analytics company IQVIA. (IQVIA’s figures are based on publicly available “list” prices, which don’t reflect the confidential discounts that are increasingly common in the global pharmaceutical industry.)
“Janssen seeks to fund not-for-profit and charitable patient organizations where there is an unmet need for education or advocacy and where such advocacy supports patient access, patient safety, patient and physician choice, and continued medical innovation,” Teresa Pavlin, a Janssen spokeswoman, said by e-mail.
The company’s internal health-care compliance team reviews requests and offers unrestricted grants to the groups selected. The company receives more funding requests from patient-advocacy groups than it can satisfy, Ms. Pavlin added.
Arthritis Consumer Experts (ACE) – a not-for-profit education, research and advocacy organization founded more than 20 years ago by Cheryl Koehn, a former Olympic volleyball player with rheumatoid arthritis – is another of the patient groups that Janssen began turning away two years ago.
Ms. Koehn says both Janssen and AbbVie regularly provided unrestricted grants to ACE − which receives between 55 per cent and 65 per cent of its funding from the private sector, including pharmaceutical companies − until the group launched its “BioSim Exchange,” an online hub about biosimilars. ACE also came out in favour of carefully transitioning patients to cheaper biosimilars to save money for the health-care system.
“Generally speaking, they [Janssen and AbbVie] both felt that section of our site presented perhaps an over-exuberant viewpoint on biosimilars. They felt it was not balanced,” Ms. Koehn said. “We told them it was a fair and accurate representation of the evidence."
Ms. Pavlin, the Janssen spokeswoman, confirmed that the company last funded ACE in 2016, after which ACE “supported a policy position that we believe undermined patient and physician choice.”
AbbVie also quit funding ACE after 2016. A spokeswoman for that company initially told The Globe that ACE did not submit any formal funding requests for 2017 and 2018.
However, Ms. Koehn provided a string of e-mail correspondence between ACE and Caroline Goyette, AbbVie’s community-relations manager, that show the group did, in fact, submit a formal request to AbbVie for a $60,000 grant for the year 2017.
Ms. Goyette encouraged ACE to reduce its request to $25,000, which it did. “This is exactly what I needed and I should be able to draft an agreement very soon,” Ms. Goyette wrote in an e-mail to ACE on April 3, 2017. AbbVie ultimately rejected ACE’s reduced request in June, 2017.
Ms. Koehn said she was “gobsmacked” by the reversal. “This is a company that has actually stepped up and supported good not-for-profit work in our community … They have never tried to influence us until we put up those pages [about biosimilars] on our website. Little did I know what would happen.”
Asked about the e-mails, a spokeswoman for AbbVie wrote that ACE’s request did not “meet the requirements” of the company’s policies and procedures, but she declined to elaborate.
One reason for the slow uptake of biosimilars in Canada is that provincial governments – whose catastrophic-drug plans usually cover expensive biologics such as Remicade – have elected to keep paying for the original versions for existing patients. New patients are covered only for the biosimilar (except in Prince Edward Island), but existing patients are grandfathered in.
If politicians were to rescind those grandfathering policies, they could risk a backlash from groups such as Crohn’s and Colitis Canada (CCC), a national charity that has lobbied against compelling patients to switch en masse to biosimilars.
CCC received about 14 per cent of its $14.9-million in revenue last year from corporations, including from Janssen, which sponsors Camp Got2Go, the organization’s sleep-away camp for children and teens with inflammatory bowel disease.
Crohn’s and Colitis Canada also receives funding from a slew of other pharmaceutical companies, including Pfizer and Merck, which make cheaper biosimilars that compete with Remicade. Like all the groups interviewed for this story, Crohn’s and Colitis Canada said it has strict internal policies to prevent pharmaceutical companies from having any say in their work.
In 2016 and 2017, the organization spearheaded a “No Forced Switch,” campaign that saw more than 4,500 patients and their supporters send form letters to government officials across the country. Such patient-led efforts can put elected officials in a bind, according to Ms. Batt, the bioethics professor.
“They feel kind of helpless,” she said. “They don’t want to look like heartless bureaucrats … But if there is a biosimilar with a much lower price, it’s just a responsible allocation of funds to switch people.”
The situation is not that simple, according to Mina Mawani, chief executive of Crohn’s and Colitis Canada. The inspiration for the No Forced Switch campaign came not from Janssen or any other drug company, but from patients who feared that switching to a biosimilar could jeopardize their hard-won good health.
Crohn’s disease and ulcerative colitis are debilitating diseases of the gastrointestinal tract that can cause gas, bloating and dozens of painful bowel movements a day. Patients often try many medications before finding one that eases their symptoms, Ms. Mawani said.
“Stability is the most important thing for patients,” she said. “The last thing [patients] wanted was to be told that, ‘You’re going to be taken off this drug – not because you’re not doing well on it, but because [the biosimilar] is cheaper.' ”
Gail Attara of the Gastrointestinal Society, another patient organization, agreed, adding that there are far fewer powerful biologic drugs for patients with inflammatory bowel disease than there are for patients with inflammatory arthritis, the other category of diseases that Remicade and Humira treat.
The Gastrointestinal Society, which received a little more than 60 per cent of its funding from corporations – including drug companies – last year, was one of the five patient groups that kept their names on the Janssen and AbbVie-funded focus-group report that the spondylitis group pulled out of.
It rankled Mr. Mallinson, now retired from his role at the spondylitis group, that the report − which was to be presented at a Health Canada workshop − drew its conclusions from focus-group participants who didn’t know much about the complicated topic of biosimilars.
But Ms. Attara said the fears that patients expressed during the focus groups echoed what she had already seen in larger surveys of better-informed patients. “All of it resonated with the way our [patient] population sees these things: They’re terrified of switching.”
The Arthritis Society of Canada, the national charity that led the focus-group project, has since had second thoughts about Janssen and AbbVie’s role in the report. The companies contributed an appendix to the final product. The Arthritis Society, which receives less than 5 per cent of its funding from drug makers, strengthened its internal safeguards in June to make it clear that no financial sponsor is allowed to influence its initiatives.
“In the presence of our new policy,” said Sian Bevan, the society’s chief science officer, “the funder’s input into the writing of a report would not be permitted.”