We’ve got good people and evidence

All we need now are good institutions

by Alan Cassels

Consider just a few classes of drugs that are pretty universally, but irrationally, used. For example statins, drugs that lower cholesterol, likely produce very little benefit for the vast numbers of the population who swallow them, and some are harmed in the process. Antihypertensives, drugs that lower blood pressure, are prescribed to seniors to such an extent that they are more likely to increase the risk of hip fractures than prevent a heart attack. And attention deficit disorder drugs are often prescribed to boys who can’t sit still in boring and unstimulating school classes.

These are just three examples emblematic of the problems of overuse and inappropriate use of pharmaceuticals, in which we see major waste in drug spending and possible harm to the population.

Even though physicians want to do the right thing, and we consumers are often reluctant to take drugs if we don’t absolutely need them, why do we see so much irrational pharmaceutical consumption? What if I told you part of the answer comes down to politics? For a provincial government that spends upwards of $1.5 billion per year on medications, decisions around drug coverage and prescribing policies are often political, not medical.

Ensuring that drugs are only prescribed when needed, to patients who would derive great benefit from taking them, needs to be reinforced by a system based on good scientific evidence, not politics. So how do we get there?

What we’ve seen in BC and around the world is that when a democratically elected government enacts policies that lead to rational and better prescribing (sometimes causing drug companies to see their profits suffer), the pharmaceutical industry will not hesitate to resort to all manner of political games. And when those fail, they use the courts.

We saw this in 1996 when BC PharmaCare was sued by Big Pharma under the banner of PMAC (Pharmaceutical Manufacturers Association of Canada) for implementing evidence-based drug coverage rules that saved the taxpayers millions. At stake was a policy of paying for a ‘reference’ price in a class of drugs, forcing the competing drug makers to lower their prices. It worked and was supported by both the public and the courts (Big Pharma lost the lawsuit), but it also sent a clear message to future governments: you will anger us at your peril.

About a decade ago, Big Pharma also sued the National Institutes of Clinical Excellence (NICE) in the UK. This group examines the evidence of benefit and harm of new pharmaceuticals and then makes recommendations on whether the drugs should be covered in UK’s National Health System. They have turned down drugs for colon cancer (Avastin) that show little benefit and drugs for Alzheimer’s (Aricept), which are widely prescribed but almost completely ineffective, if not harmful. Whenever a government has good scientific evidence to show that coverage of a drug or certain class of drugs is not in the public interest, one major tactic from Big Pharma is to destroy the group that produces the evidence.

That’s one tactic we’ve seen here in BC with our own group, the Therapeutics Initiative (TI) at UBC, whose commitment to the evidence make them a natural drug industry target. Over the years, the drug lobbyists, speaking into the ears of legislators, have said the TI has an anti-drug bias and isn’t transparent when it comes to assessing new drugs, but I would disagree. As a group that favours conservative, rational prescribing, in contrast to the hucksters out there, the TI’s advice to doctors is that they shouldn’t use a new drug until there is positive (and independent) evidence of benefit.

Now that we have a new government in BC, or at least the political structure where compromise and consensus will be necessary, it’s prime time to create a system shielded from the political power of the pharmaceutical industry. Because pharmaceuticals are such a vital, costly and central part of our health system, any reforms brought in on the provincial health front must be structured to reduce the waste and inefficiency in the drug budget. And those reforms must be resilient, above politics so to speak, to ensure they can’t be thrown aside the moment one drug company is upset because their blockbuster drug isn’t deemed worthy of public coverage, and they send their lobbyists to sort out the Minister of Health or the Premier.

There is a short list of examples of models from around the world to emulate. A group in Ontario called ICES (Institute for Clinical Evaluative Sciences) gets provincial money to evaluate drug evidence and medical procedures and they are independent from government. The scientists who work there are (generally) protected from the mud-wrestling of provincial or pharmaceutical politics so their reports can be trusted. And as previously mentioned, there is NICE, established in the late 1990s as part of the UK’s Department of Health, and now called NIHC, the National Institutes for Health and Care Excellence). While it has weathered political attacks, the structure of the organization as an independent agency allows it to sustain pharma’s frequent criticism, emboldened to serve the health care needs of UK’s citizens.

The new NDP-Green accord is getting set to run the province. One of their platforms is to get back to essentials and implement an “essential drug program.” This is a fabulous idea, but in order to determine what is essential from the drug cabinet, you need weapons-grade expertise and a resilient political structure to be able to withstand Pharma’s political slings and arrows. Making provincial-level decisions about what new drugs to cover, needs, most of all, scientific certainty, untainted by the manufacturer’s one-sided view of the value of their products.

Such a structure should be like the Therapeutics Initiative, funded for studying evidence and supplying government decision makers with distilled summaries of research to support the hard decisions on drug funding. The TI’s UBC affiliations have been helpful in fending off pharma attacks, but this new institution would need multi-year, stable funding. You could easily fund such an institution by halting the automatic coverage of classes of drugs that are deemed unnecessary, unhelpful and possibly harmful. Hmm, maybe statins for everyone, antihypertensives in the elderly or ADHD drugs in children?

Providing independent and science-based decisions around drug coverage decisions would make such an institution a big target of Pharma’s attacks. In fact, the more successful it is in asserting evidence around the value and cost effectiveness of new drugs, the more it will be hated by Big Pharma, and their minions, including specialists and patient groups who are often used as Pharma’s foot soldiers in battling for the control of the public narrative.

Why is now the time for such an initiative? For starters, the Green Party says they are committed to evidence-based policy and so it makes sense they’d be natural supporters of making evidence and evaluation centrepieces of healthcare services. They want to get the ‘big money’ out of politics and policymaking so what would be better than an agency free from political influence to produce evidence on policy and program effectiveness, protected from Big Pharma and other vested interests?

We’ve seen groups like NICE or ICES have a big influence on policy and practice, free from the whipsawing of politics and able to focus on local policies and programs. In BC, we have another great asset in our PharmaNet system so that rapid, low-cost evaluations of drug policies can happen. We’ve been world leaders and we have some of the best scientists able to use these administrative databases to study drug policy. What we need now is a politics-free institute to house them. A great opportunity for a new government in this province.

Alan Cassels is a writer and former drug policy researcher. His latest book is The Cochrane Collaboration: Medicine’s Best Kept Secret. Follow him on twitter @AKECassels

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