Healthy Skepticism Library item: 12222

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Cassels A.
Who reads those Health Canada advisories anyway?
CBC News 2007 Dec 18
http://web.archive.org/web/20110120002733/http://www.cbc.ca/news/viewpoint/vp_cassels/20071217.html

Full text:

Large volumes of drugs are prescribed and used in North America even when they carry clear danger warnings. This is particularly evident from the recent research done by CBC in examinaing the atypical anti-psychotic class of drugs, where the growth in the use of such drugs continues despite clear advisories mandated by Health Canada at least three times in the past five years.

Generally, the public tends to have a high degree of trust in the regulator (Health Canada or the U.S. Food and Drug Administration) to keep unsafe drugs off the market. We expect that they track and monitor safety signals that come from the field, assert their authority to demand a closer look at a company’s data, and issue warnings when necessary so that those drugs can more safely be used. We expect that the regulator makes considerable effort to warn prescribers and advise consumers that there may be safety concerns worth noting.

And we cannot be faulted for thinking that the regulators issuing warnings to physicians or notifications to the media regarding new safety information actually care whether those warnings reach prescribers and the public.

(Drug advisories
A timeline of warnings for the newer, “atypical” anti-psychotic drugs: olanzapine (Zyprexa), risperidone (Risperdal) and quetiapine (Seroquel):

Oct. 11, 2002: Janssen-Ortho Inc., maker of Risperidone, issues a letter to health professionals with a black box warning of cerebrovascular adverse events (CVAEs) with use of Risperidone in elderly patients with dementia.
March 10, 2004: Eli Lilly, maker of Olanzapine, issued a letter to health professionals with a black box warning of the danger of CVAEs associated with use of Olanzapine among elderly dementia patients.
June 22, 2005: Health Canada advises health care professionals of the increased risk of death associated with atypical anti-psychotics and that these medications are not approved for use in elderly patients with dementia. Risperidone is the only atypical anti-psychotic approved for patients with severe dementia.)

Now it’s time for a reality check.

For starters, to say that our Adverse Drug Reaction (ADR) reporting system is a lame duck is an understatement. It is a voluntary system and there are no incentives for anyone to report ADRs, which means even gathering data on a drug’s safety in the “real” world may take a long time and cost a lot of bodies.

Let’s compare aircraft safety to drug safety. If you asked an official at the Transportation Safety Board of Canada how many planes fell out of the sky last year, which planes they were and how many people died, and the answer was, “We don’t know,” you’d be a bit leery about ever stepping on a plane again. But that’s roughly the answer you’d get if you asked Health Canada how many drug disasters we had last year from routinely prescribed drugs. They wouldn’t be able to tell you which drugs were involved or how many people died, or were injured, never mind getting into the details.

In terms of issuing warnings or guidance, it isn’t until Health Canada collects a sufficient volume of ADR reports that further investigation is triggered – and that could take a long time. If the reports on a drug start to pile in, Health Canada may ask for additional company data and start to negotiate a label change with the manufacturer. That’s like asking the aircraft manufacturer’s opinion on how to word the fact that certain types of engines on their planes may fall off.

Sound like a bizarre system? It is.

Federal regulators don’t issue drug safety warnings lightly; sometimes after months of negotiations with the company, the government may decide to send a warning letter to health care professionals and the media. Yet there is no tracking to see if those safety warnings, which are often written in technocratic legalese, ever reach their intended targets.

And there is little examination to see if the letters have an impact on drug use. We shouldn’t have to rely on our national broadcaster to do this kind of legwork to see if the drug warning has had any effect.

The public needs to know that any drug warning issued by Health Canada should be read closely and carefully. Preferably, you need a skilled clinician who is aware of the euphemisms and guarded faux-optimism these warnings sometimes carry.

Ultimately, you need to understand that the real risk underlying the warning could be much more serious than it sounds, and that the warning ultimately exists as a compromise between the regulator and the company.

Sometimes, drug safety warnings are so widely ignored in the “real world” as to seem unbelievable. There are many examples to choose from, but the series of warnings related to anti-psychotic drugs – drugs developed for schizophrenia – and their use in seniors with dementia is probably one of the worst examples I’ve seen recently.

Over the past five years, at least three advisories in Canada were issued related to the serious adverse events of these drugs when taken by elderly patients with dementia. Did these advisories change the rate at which physicians prescribe the drugs? Not at all. By all accounts, those drugs continue to be widely prescribed to seniors.

So, in addition to other stories of abuse and neglect of seniors in long-term care in Canada, let us add one more scandal: Many of those seniors are routinely prescribed drugs with a range of serious and potentially even fatal side effects.

Despite the warnings of a higher risk of cardiovascular events such as stroke, transient ischemic attack and sudden death due to heart failure, why is the number of seniors exposed to these drugs climbing? Do we really need to be causing even more seniors to experience the jerky, restless involuntary movements of the hands, fingers, arms or legs on top of sedation, confusion, restlessness and nervousness?

Is it really possible that no one – not the regulators, the physicians or even the patient advocates – is aware of how widely these drugs are used in this most vulnerable population?

What lesson to take away from this?

Any drug you are currently taking could come with warnings, and to keep yourself and your family safe, you need to read and understand these warnings. You have to ask your doctor if he or she has seen the regulator’s warnings and you need to start exploring safer options.

But steel yourself; second-guessing your doctor’s prescribing is not an easy conversation to get into. Physicians are routinely unaware of drug warnings, not just because Health Canada does a seemingly lacklustre job of warning them, but because we’ve relegated the education of our physicians largely to pharmaceutical companies. Drug companies are known to routinely fund the continuing medical education of our doctors, and their sales representatives make regular visits to our physicians’ offices to make sure any questions about their product’s safety can be “clarified” with the company-sponsored message.

Until Health Canada proves that the warnings it issues are clear and widely disseminated to, and understood by, physicians and the general public, patients need to take their own precautions to prevent any risks.