Seniors targeted with expensive high-dose flu vaccine

The government doesn’t pay for it yet, but the pressure from Big Pharma is on.

IN THE FALL OF 2016 a new flu vaccine became available in Canada, promising to provide much better protection for senior citizens. Known as a high-dose trivalent inactivated vaccine (HD-TIIV) and sold under the brand name Fluzone, the vaccine was promoted as a weapons-grade tool in the fight against the flu among our most vulnerable population—seniors. We were told it contained four times as much antigen compared to standard-dose quadrivalent inactivated vaccine (QIV), for the three strains the vaccines share in common.

While this is not the first time I’ve tried to inform Focus readers about campaigns to shape our thinking about diseases and drugs, or questioned whether the best available evidence supports mass influenza vaccination, the high dose of propaganda floating around this flu season seems particularly noxious. The drama hinges on a key question: Would millions of dollars more—either from BC taxpayers or the pockets of seniors themselves—make any real difference to the annual burden of influenza?

The so-called “awareness-raising” (mostly by industry) around this new flu vaccine is not only exposing all of us to the scariest of statistics around the flu, but seniors’ groups, doctors and pharmacists have been even more intensely targeted. “Seniors are at high-risk for the most severe consequences of flu, including hospitalization and death,” we are told in ads and public service announcements, adding that “up to 91 percent of flu-related deaths occur in those 65 years of age and older.”

Repeated public health appeals to get the flu shot seem to be singling out older people and their weaker immune defenses, but for me this targeting raises a contentious question: If the flu is so bad, how many people die of it every year?

The Public Health Agency of Canada, which runs the FluWatch program, says they get, on average, 23,000 lab-confirmed cases of influenza reported to them each year. Acknowledging that the “burden of influenza can vary from year to year,” they estimate that in Canada there are an average of 12,200 hospitalizations related to influenza, and approximately 3,500 flu deaths every year. These are projections, based on modelling, but that 3,500 number gets repeated ad nauseum. But is it true? Two months ago, a CBC story reported actual FluWatch data that said Canada had 302 flu deaths last year.

In whose interest is it to exaggerate these numbers?

I guess it only matters when you thoughtfully consider what game is going on. As every marketer knows, you don’t sell the steak, you sell the sizzle. Big Pharma is happy to have the projections and estimates sound dramatically scary, even if they are as much as ten times inflated from reality.

In Canada, a national body called the National Advisory Committee on Immunizations, or NACI, said that Canadians over 65 should be offered this high-dose flu vaccine on the basis of “good evidence of better efficacy compared to standard-dose” flu vaccines. They suggested that older people suffer from “immunosenescence”—a waning immune system as they age—and hence older people are at greater risk of severe illness from the flu. This apparent need for stronger stuff buttresses the case that an “extra strong” vaccine is needed to protect our seniors.

NACI’s Canadian Immunization Guide said that Canadian provinces “may use any of the four influenza vaccines available for use in adults aged 65 years and older: standard-dose TIIV, the HD-TIIV, adjuvanted TIIV, and QIV (quadrivalent influenza vaccine).” However, the organization also recommended “at an individual level, the HD-TIIV should be offered over standard-dose TIIV to persons 65 years and older because of the expectation of higher effectiveness.”

This means it’s better, right?

Others aren’t so sure. The BC Centres for Disease Control looked closely at the science behind the vaccine and said additional studies were needed to confirm whether the HD-TIIV vaccine’s effects are consistent “across seasons and vaccine strains.” They also said they didn’t know if the vaccine “warrants preferential recommendation and public funding over other available options.” The new high-dose vaccine costs about $80-$90 per shot, about five times as much as a standard flu shot. Saying yes to the vaccine would cost BC taxpayers millions more than we already spend. This would be money well spent if it saved more lives and kept more people out of the hospital, but…let’s dig into the numbers.

The pivotal trial of HD-TIIV enrolled more than 30,000 people comparing it to standard-dose TIIV. The results? The HD-TIIV reduced the risk of influenza by 24 percent. It sounds pretty impressive, but what does that number really mean? The study, carried out in seniors who lived in their own homes, found 1.9 percent of those getting the standard-dose vaccine developed the flu, versus 1.4 percent who got the high-dose vaccine. While it’s a 24 percent drop to go from 1.9 to 1.4, it’s also a 0.5 percent difference (1.9 percent subtract 1.4 percent = 0.5 percent). This means that half a percent of seniors were saved from the flu. The CDC concludes that “an additional 200 such individuals would need to be immunized with the high-dose product to prevent 1 additional case of influenza.” Also, one person in 4,000 vaccinated would avoid a hospitalization. The high-dose vaccine showed no effect on deaths.

So if you trust the study, the HD-TIIV vaccine increases grandma’s chances of avoiding the flu by 1 in 200. The converse of this is that 199 of every 200 people vaccinated with the HD-TIIV will see no benefit. The researchers’ conclusion and recommendation to the Ministry of Health speaks volumes: “the strength of the evidence and anticipated incremental benefit of HD-TIIV relative to standard dose TIIV is not commensurate with the additional 5-fold cost...”

As of press time, the BC Ministry of Health seems to agree. It does not cover the HD-TIIV, likely because it costs five times as much but doesn’t help 199 of the 200 people who get it. My back-of-the-envelope math says that for $16,000, the high-dose flu shot will help prevent one additional flu case in seniors; it would cost $320,000 to prevent one hospitalization (that’s just for the vaccine, not for administration costs). And there is no evidence the high-dose vaccine saves lives.

For drug companies in Canada, however, the big enchilada in sales is provincial coverage. If their drug or vaccine isn’t covered by the provincial government, their profits will be smaller, and they will have to rely on people paying out of their own pockets or having private insurance.

Among Canada’s 13 provinces and territories, only Ontario funds the HD-TIIV for all adults aged 65 and older. Saskatchewan, Manitoba, Nova Scotia, P.E.I. and Northwest Territories cover it for seniors in care facilities. BC does neither.

But the pressure is on. Over the last year I became aware of at least four different Canadian seniors’ organizations who have been lobbied by the company promoting the high-dose vaccine. The company offers conference speakers, workshops and webinars to “educate” seniors about the threat of influenza and the benefits of various vaccines. The punchline: You deserve the best, so lobby your government to pay for this vaccine! (The BC Liberal Opposition introduced legislation in October to cover costs of the high-dose drug for seniors.)

These promotions have the veneer of being public-spirited and helpful, especially when the companies propose their own speakers to educate senior’s groups, offering free sessions on the dangers of influenza and so on.

Putting vulnerable seniors into the cross hairs of big Pharma’s direct marketing tactics doesn’t please everyone. One member of a seniors’ organization based in Vancouver (who asked that his name not be used) was blunt with me: “Sanofi, the third-largest drug corporation in the world, has generously provided expensive restaurant meals and delivered their sales pitch to retired teachers’ groups in BC as part of promoting their new and very costly flu vaccine.” He added that “BC seniors cannot easily access independent information about the efficacy of new drugs, and neither can family doctors for that matter, so some seniors are now lobbying their provincial government to cover them. Constant TV advertisements marketing these new vaccines reinforce a message of fear and the need for urgent preventative action.” Also jumping on this bandwagon are a variety of national patient and seniors groups “partnering” with the vaccine makers to sponsor flu awareness campaigns.

There is evidence that the marketing to health professionals is also in full action mode, and the way this works is usually through the digestive system. The manufacturer will sponsor a dinner at a nice local restaurant and invite community pharmacists or local GPs to attend a dinner lecture. They’ll either feature their own “Key Opinion Leader” or work with a local GP or pharmacist to deliver the goods with a company-provided slide deck. Don’t be shocked, this is Drug Marketing 101, and a time-worn way for the company to make sure our doctors and pharmacists buy into their version of this lifesaving vaccine.

All this is perfectly legal, of course, despite the fact the doctors and pharmacists I know become somewhat red-faced when I ask them what they think of their colleagues being wined and dined with company presentations and other pharma-funded schmoozing.

What can we do about this? I’d recommend a much higher dose of skepticism among the public and our health professionals as a partial antidote. We need to be reminded that we allow this kind of sneaky marketing and flu-mongering at our peril. But here’s my big worry: Maybe the growing distrust that many Canadians feel around flu propaganda will lead to a greater public reaction, causing fewer and fewer people to trust what they are being told about the value of other vaccines.

Alan Cassels is a Victoria-based drug policy researcher and author whose motto is “We need clean, clear health information as urgently as we need clean, clear water.” He works for UBC’s Therapeutics Initiative but the opinions represented here are his and his alone. Follow him on twitter @akecassels.