Change pharmacovigilance reporting rules, govt is told

Source - PharmaTimes

My thoughts in blue text


Change pharmacovigilance reporting rules, govt is told
28 October 2008

The law needs to be changed to make it clearer to drugmakers when they should report new information which might influence the evaluation of a medicine’s risks and benefits to the Medicines and Healthcare products Regulatory Agency, the government has been told.

All this time and it needs to be changed NOW? Isn't this a bit like saying, If your house has asbestos then it could pose a danger to your health? Why the delay?

In particular, there is a need for more guidance on what to report within what timeframe, and for further clarity over use of the terms “promptly” and “due diligence,” respondents (mainly manufacturers) have told the public consultation held by the MHRA on the issue.

Here we go again with semantics. Addiction or discontinuation syndrome? Stop beating around the bush and tell it like it is! It is simple, stop confusing the issue because you are confusing the patient! [Maybe that it the goal here?]

The consultation was launched to discover if the current law – The Medicines For Human Use (Marketing Authorisations, etc) Regulations 1994 – needed to be changed, following the MHRA’s report earlier this year of its investigation into whether GlaxoSmithKline had failed to inform it in a timely manner about information which it had on the safety of its antidepressant Seroxat (paroxetine) when used in patients aged under 18.

Consultation? What or whom was there to consult? There is no debate about this, stop wasting time and money and pull your finger out of your ass and stop this negligence, because that's exactly what it is!

Based on the findings of the investigation and legal advice, government prosecutors decided that that there was no realistic prospect of a conviction and that the case should not proceed to criminal prosecution.

This still sticks in my throat. If this crime [because that's what it was] was committed against the government then they would have pulled out all the stops to get convictions. They would have, at the very least, made arrests and interviewed the 'suspects' under caution. The public were let down with this investigation. I know the MHRA's hands were tied but their excuse for making no arrests and not interviewing suspects just does not wash with me. The only reason I can see why no arrests were made was because mud sticks and I see this as the MHRA protecting the criminal rather than the public!

However, the legislation in force at that time was not sufficiently clear or comprehensive as to require companies to inform the regulator of safety information when the drug was being used for, or tested outside, its licensed indications, says the government, in its response to the consultation.

Tell us something we don't know! We [the public] were told this after the MHRA investigation. I'll ask again, why did you waste time and money with this consultation?

There have been several European Union developments since the Seroxat case, including the new clinical trials Directive and legislative changes to clarify the obligation to report, "promptly," relevant safety information arising from clinical trials using products outside their normal conditions of use.

Remind me again, what does "promptly" mean? Just so we are all clear.

The European Commission is also proposing to strengthen the EU system for monitoring the safety of medicines but, given the length of time that this may take, the MHRA has committed to changing UK legislation in the interim to clarify the requirements.

And approx how long will that take? Has it started already? Are new drugs being evaluated with the proposed criteria yet? Have Pharma been told that they must report new information "promptly" yet?

Therefore, the proposed changes to the 1994 Regulations will state explicitly, to ensure there remains “no room for doubt in industry’s and regulators’ minds,” that Marketing Authorisation (MA) holders should report information from both clinical trials outside the licensed indication and arising from third countries and to provide a timescale for reporting, says the government.

Which begs the question why this matter was overlooked in 1994? Who was responsible for this error of judgement, have they been reprimanded?

Points from the consultation
The MHRA’s review of the consultation says that a number of respondents - including the Faculty of Pharmaceutical Medicine (FPM), Wyeth, the British Association of Research Quality Assurance (BARQA), the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIO) and the mental health charity Mind – expressed concern over the use of the word “promptly.” As a result, it says, the proposed new legislation will use the term “as soon as reasonably practical” instead.

What a joke! So years down the line a pharmaceutical company can once again slip through the loop by claiming "Sorry, but it wasn't reasonably practical to release the information". Good to see that Pharma were at this 'consultation'. Here is something for you all, how about the proposed new legislation states: "...the very second you learn of new information you MUST report it". It ain't rocket science and hey, you may just save a life or two!

The ABPI also felt there should be guidance on what type of information is caught, in which time frames this needs to be reported and when the clock for such reporting starts, while the BARQA said the MHRA’s preparation of the new regulations should provide a clear audit trail of the underlying legislation, so that MA holders “could understand at a glance exactly what is required of them, especially when severely punitive sanctions apply to non-compliance.”

Here's a scenario for you: I'm a scientist and for the past ten years I have been studying washing powder. I have unequivocal evidence that it causes skin cancer, every single brand. Do I sit on this information or do I refer to the 'new legislation' to see whether or not I should report it at a certain time? C'mon, you are playing right into the hands of Pharma here. How would you feel toward me if your child got skin cancer from washing powder and you learned that I knew about this but said nothing because I didn't have to? It's pathetic. You are merely allowing Pharma an extension to manipulate figures so their product does not lose them money... and lets face it, without Pharma's money, the MHRA would not be able to function.

Among other comments: - the BIA called for guidance on the MA holder’s obligations for reporting safety information arising from non-company-sponsored trials; - Flynn Pharma Ltd pointed out that if the same products are marketed by different countries inside and outside the European Economic Area (EEA), UK-based MA holders might not be informed of problems occurring outside the EEA; and - Merck Sharp & Dohme noted that MA holders might not be made aware of the results of clinical trials sponsored by academic investigators which could affect the their product’s risk-benefit balance prior to such trials being made public and that, until they obtained such knowledge, they would be unable to report such results to the regulator. The BIA raised similar concerns, particularly in areas such as oncology, where trials are often designed and conducted by clinicians and academics acting independently from the MA holder.

How about someone from the MHRA contact every single Pharmaceutical company every month and ask: "Anything to report?" - If they say "No" and it is later found out that they did indeed have new information then the MHRA can say that it was lied to. You are really making a mountain out of a mole hill here. It's so simple. Remember how you used to tell your children, "Don't talk to strangers"? How pissed would you be if you learned one of your children had spoken with a stranger and kept it from you? You would warn them of the importance to tell you wouldn't you? Same thing applies here because if you don't get it right this time then you will allow Pharma to make you look even more incompetent than they did over the GSK investigation fiasco.

I'm a patient, I give you the above advice free of charge... and I didn't need a room full of Pharma execs!

Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

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