Beware Regulators Bearing Gifts

All of a sudden, regulators seem to be trying to step up their game. The Canadian regulator, Health Canada, is placing notices in 22 professional journals explaining the process of and the importance of adverse event reporting. They claim to be hoping to develop a reporting standard among healthcare professionals rather than make reporting mandatory.

Are they really doing something or just managing perceptions created by adverse reporting by the Toronto Star? Risk management for regulators is all about managing the perceptions of the public in any way other than tackling the hazards of drugs.

At the same time Britain’s regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), is also trying to step up efforts to get doctors to report. The rate at which British doctors report has fallen from 5,578 reports in 2003 to 3,511 in 2012. Reporting was extended to the public in 2006 but after a brief flurry this has also shown a drop from 3,548 in 2006 to 1,789 in 2012.

Could it be that both regulators are responding to RxISK? During the 4 months it has been in operation RxISK has generated almost a 1000 reports of side effects. It already has more electronic reports than MHRA has and will almost certainly have more side effects reported this year than MHRA.

RxISK challenge to regulator?

Are regulators stepping up their game in response to the challenge? Are they really concerned about the fact that adverse events account for 1 in 16 hospital admissions and 4% of hospital bed capacity, as MHRA’s press release says? Are MHRA really trying to build on their record of detecting adverse events – such as their claim to have detected the risk of seizures in people taking the smoking cessation drug buproprion?

The first point to make is that RxISK has put in place an option for anyone reporting to it to have their report sent to Health Canada or MHRA or FDA or your national regulator. So increased reporting to RxISK is a way to increase reporting to your national regulator.

Why RxISK and not FDA or MHRA or Health Canada?

Are there any reasons to report to RxISK rather than directly to your national regulator? Several.

First, regulators like FDA, Health Canada and MHRA are constitutionally averse to linking a drug to a problem. They will only do so long after the problem has been widely recognized. On average problems ranging from promiscuity or gambling on dopamine agonists to suicidality on antidepressants are recognized by doctors and patients for 20 years before regulators get round to including them in the warning labels on drugs.

In the case of seizures on buproprion, MHRA’s claims to have led the way on this problem are bizarre. The drug was on most major markets for almost two decades before it was licensed in the UK for smoking cessation. Its capacity to cause seizures was well-recognized from the late 1980s, and led to warnings elsewhere.

In the case of thalidomide the response from authorities was to hold open the possibility that what the drug did was to prevent spontaneous miscarriages so that children without arms and legs who would not otherwise have been born were now being born – but it didn’t cause these babies to be born limbless.

In the case of Matt Miller, a 13 year old who committed suicide after a week on Zoloft, they suggested that this might be auto-erotic asphyxiation gone wrong.

So if anyone thinks more reporting to regulators is going to lead to more recognition of links between drugs and problems, think again. It won’t. Increased reporting to regulators on its own is like pouring water into sand.

Companies want you to report to MHRA, FDA and Health Canada – why?

As proof of the pudding, consider this. Companies have taken in recent years to encouraging patients to report to doctors and to report directly to FDA rather than report to the company making the drug. Why? Because, companies have a duty to follow up patient reports over time and attempt to establish causality but FDA and other regulators don’t. So getting people to report straight to the regulator is a way to reduce legal liability, reduce reports from patients and doctors to anecdotes, while at the same time saving on the costs of running a pharmacovigilance department.

It’s difficult to avoid the thought that Health Canada and MHRA are in fact doing exactly what companies would wish. Reporting to Health Canada and MHRA through RxISK in contrast means that we can all know just what data the regulators have and this puts us in a position of being able to ask the regulator to step up to the plate and agree that some of the reports from patients and doctors are quite compelling and should be acknowledged in the labelling of the drug.

Patient engagement – the next blockbuster drug

Meanwhile in another part of town, Health Affairs have run an issue on patient engagement – calling it the next blockbuster drug. Engaged patients are able to manage themselves better and this leads to lower healthcare costs.

The best way to engage doctors in reporting is likely to be if you face them clutching a RxISK report and tell them that this report has already been submitted to Health Canada, MHRA or FDA. MHRA say they are aware that doctors are very pressed for time and this makes reporting difficult. But, if only because they are now put in a very different legal position, doctors are likely to find time to engage with you and to complete a report.

And if several of us and our doctors think there is a likely link to the drug, because perhaps the problem clears on stopping the drug but reappears on re-exposure, we are going to put Health Canada, FDA and MHRA into a position of having to step up to the plate.

Besides why should we wait for FDA or MHRA or Health Canada to say this drug may come with risks – we don’t do this for foodstuffs like butter or chocolate or meat. It is consumer groups that decide if this is good butter or not, and physicians who decide if butter is good for you – not food regulators. Why should it be any different in the Drug part of the Food and Drugs Agency?