DRUG BUST Alan Cassels

If you’ve visited a health food or vitamin store in Canada recently, you’re no doubt aware that the federal government wants to change the way it monitors and regulates the health products you use.

There are dozens of bills before parliament right now, but none are generating as much ink or email as the proposed Bill C-51. In attacks led by the folks in the natural health products industry, the Bill’s main point of contention is the government’s wish to lump natural products and pharmaceutical drugs together under one regulatory umbrella. If Canadians are going to keep putting things into their mouths, those things do require some level of government oversight, regardless of whether the product was manufactured in a lab or drawn from a plant.

The volume and virulence of the attacks on Health Minister Tony Clement have been intense, and in mid-June, he seemed to relent. He admitted to the Vancouver Sun that maybe “It was a mistake not to create a separate category under the law.” When you consider that the vast majority of natural health products pose infinitesimally smaller risks than most pharmaceuticals, and have been used safely and effectively for generations with nary any government oversight, this distinction is a most helpful advance.

Yet even with some amendments, this bill could spell big trouble, but not because the Mounties will soon be kicking in your door to see what’s in your medicine cabinet, but because Bill C-51 will accelerate Canadians’ access to new prescription pharmaceutical products. Maybe the federal government is getting into the Olympic groove, believing that we need to enshrine the three-word Olympic motto – “Swifter, Higher, Stronger” – and extend it to drug regulation. However, those who clamour for faster access to new drugs ignore the axiom “Speed Kills,” clearly displaying an astonishingly short attention span in this post-Vioxx world.

The irony, of course, is that while you may want faster access to drugs, you certainly do not expect immediate access to drugs with safety problems. Research on this issue is quite telling. One study, which looked at the speed of approval and the safety of drugs in the UK versus the US over a 20-year period, found that relatively longer approval times in the US created more stringent reviews and fewer post-market safety withdrawals. Which is to say, if the regulator takes its time and gets it right, it won’t have to remove the drug (and bury the bodies) when things go sideways. Another study found that for every month chopped off the approval process by the reviewers, adverse drug reactions resulting in deaths increased by two percent. Here’s my reading of the data – “Speed Kills.”

In May, we were reminded just how dangerous widespread access to prescription drugs is. A study out of Florida revealed that the rate of deaths caused by prescription drugs was three times the rate of deaths caused by all illicit drugs combined. If anything, slower and more careful attention to how drugs are approved, prescribed, used and monitored may be what the doctor ordered, but will you find these kinds of safety measures in Bill C-51? Not at all. Instead, there’s a promise of “Progressive Licensing” which is a sure hit if you’re a drug manufacturer, but potentially bad news for the rest of us.

Speaking of the drug companies, here’s a skill testing question for my readers: What do our friends in Rx&D, the group of brand name drug makers in Canada, think of Bill C-51? You may be excused for not knowing the answer, as the industry’s key lobbyist seems eerily silent on the issue. Knowing that this is an industry that can lash out with the fury of a mother grizzly whenever its markets are threatened, how can we explain its tight lips around the biggest change to Canadian drug regulations in half a century? I can’t answer this for sure, but let me hazard a guess: It’s because they like it. They like it a lot.

Why?

For starters, and in the spirit of a little schadenfreude, what’s not to like about a proposed law that makes your 98-pound weakling competitor (the “natural products” industry) apoplectic with rage? Let’s face it; any law that kicks sand in the face of a competitor by blinding him with bureaucratic red tape is a pretty sweet deal on its own.

But beyond this, my reading of the new proposed law is that it’ll do three things that the brand name companies love: increase the speed with which drugs arrive on the market, keep any pesky after-market drug testing in the hands of the companies themselves, and best of all, allow the pharmaceutical industry to “talk to its constituencies.”

This last bit will also make Canada’s media industry awfully happy, as it pertains to changes to the laws around advertising drugs directly to consumers. DTCA (Direct to Consumer Advertising) is the jewel in the crown of pharma marketing – a potentially $500 million per year ad market in Canada that can transform a ho-hum or even dangerous drug into a blockbuster, through the power of persuasive ads. Will full-blown, American-style DTCA emerge from bill C-51? It’s too early to tell, but if it does, it will be as bad for your health as any product could conceivably be.

If you’re a brand name drug manufacturer, you’ll be happy to see the government speed up the approval of new drugs. One of the main problems with speeding up the drug approval process is that, since the drug companies pay a fee to have their drugs approved, the government can be penalized financially for not approving products fast enough.

This kind of pressure to go faster, instead of safer, is akin to having someone standing over your surgeon’s shoulder yelling at him to “hurry up, hurry up” as he operates on your heart. Wouldn’t you rather him take his time and get things right? Why would we expect anything different when we are judging the safety and effectiveness of a drug that will be used by millions of people?

Even though Tony Clement stated in the Globe and Mail, “There are no changes that lower the safety standards or speed up drug approvals,” you would hear nothing but howls of protest from the drug industry if the new bill didn’t implicitly promise speedier drug approvals. If Clement is wrong, and what actually emerges from Bill C-51 are tougher safety standards – that is, slower, more careful monitoring of new drugs throughout their life cycle – it will be the drug companies you hear screaming blue murder, not the natural health folks.

If you have a drug company and you want to sell your drug in Canada, there is basically an “all or none” situation: the drug either gets a licence to be sold or it doesn’t. Bill C-51 enshrines the concept of “Progressive Licensing,” which is an attempt to get drugs on the market even faster, with the promise that the drug will be followed and monitored throughout its life cycle. If this idea on its own doesn’t make you feel more like a Guinea pig than you did before, then consider this fact: the “post-marketing” studies of those newly licensed drugs will likely be financed, organized and analyzed by the companies themselves.

Sweet.

That’s right; the language of C-51 suggests that the manufacturer will be responsible for paying for, running and analyzing postmarketing studies. This will hardly provide the answers we need because there’s a pretty conclusive link between those who fund a study and the conclusions they find. Conveniently, the drug companies have been found keeping the stuff they don’t want airing in the bottom of a file drawer.

The biggest problem with Bill C-51 may have to do with both what we know and what we won’t know about new drugs. The drug companies like to talk a lot about “transparency,” something they demand from public organizations, but strenuously avoid in their own behaviour. Often, key information about a drug held by Health Canada in the course of approving it is withheld from any public scrutiny, all in the name of “business confidentiality.”

In Canada, we can’t even be told if our regulator is in the process of reviewing a drug’s application. Nor can we find out the full results of the clinical trials the ministry examined, in order to grant a licence to the company, even though Health Canada can release summaries of its decisions. Further, we can’t learn what Health Canada’s own reviewers stated about the drug trials they saw or any of the reasons a drug may have been rejected.

Transparency is vitally important for information to be independently scrutinized, and for the full picture of a new drug to be disclosed to health care professionals and the public. Yet there is no sense whatsoever that Bill C-51 is going to deliver on the transparency front.

In a nutshell, Bill C-51 possesses huge potential to cause harm to anyone who takes prescription drugs. It could expose Canadians to more ads about drugs; it could significantly speed up the drug approval process; it could require that drug companies fund and then carry out biased, post-market studies, while refusing to allow access to the efficacy and safety data that Canadians need to ensure that taking prescription drugs is a healthy and safe activity.

“Swifter, Higher, Stronger.” That’s what we expect the new regulations to be. Instead, Health Canada could end up giving further Olympian powers to the manufacturers and sellers of prescription drugs in Canada.

Alan Cassels is a pharmaceutical policy researcher and a frequent commentator on prescription drug issues. www.mediadoctor.ca alan@mediadoctor.ca

If you think you have been injured by a prescription drug, you should call the Canada Vigilance Program at 1-866-234-2345. You can also submit an adverse reaction report on the Med Effect Canada website (www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html).