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Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Friday, November 24, 2017

MHRA Promote Broken System




Yellow Card System Remains a Red Flag

This weekend the British drug regulators, MHRA, are using Twitter to promote their broken Yellow Card ADR reporting system. The Yellow Card is MHRA's initiative whereby prescribers and patients can report adverse drug events regarding prescription drug use.

Here are some recent MHRA tweets:




One would think the MHRA are finally starting to acknowledge that reported adverse drugs reactions can improve patient safety and product warnings. However, the MHRA refuses to follow up on Yellow Card reports. Thus, reporting adverse drug reactions (ADRs) has little to no value in improving public health.

MHRA should follow up Yellow Card reports by contacting doctors and/or consumers to seek relevant info regarding the reported adverse drug event so that MHRA can then determine what role ADRs played in causing harm.

Let's say Mr. Smith loses his wife to suicide. After conducting independent research, Mr. Smith learns the drug his wife was prescribed may have contributed to her demise. He then submits a Yellow Card report to the MHRA.Upon receipt of his report, the MHRA will add the adverse event to a database. MHRA won't bother following up. They won't contact Mr. Smith to ask pertinent questions such as, "Did Mrs. Smith's mood worsen when she was talking the drug?" or "Was Mrs. Smith warned by her prescriber that the product is known to create suicidal thoughts and actions?"  Instead, the MHRA will merely add the adverse event to their database where it will sit for infinity without further investigation.

When consumers alert the MHRA that the adverse event might have possible causation, the MHRA routinely claims, "correlation does not equal causation." I say routinely because the MHRA failed to follow up Yellow Card submissions and can, therefore, continue to claim there's "no correlation."

As a patient advocate, I have, in the past, alerted the MHRA that there were 79 reported cases of suicidal and self-injurious behaviours on the same drug. (Paxil) If Paxil was the product Mrs. Smith was taking at the time of her death, the MHRA would again parrot their "correlation does not equal causation" line. Mrs. Smith's ADR then becomes just another suicide that has very little to do with the drug she was taking.

By promoting the Yellow Card reporting system on Twitter, the MHRA is asking prescribers and consumers to continue sending reports that the MHRA will never follow up. Even if the suicidal and self-injurious behaviours statistic for a particular drug increase, the MHRA will always be able to claim that just because people die of self-inflicted injury whilst taking a prescription drug, it doesn't mean the drug caused the suicide.

This works well for the MHRA but doesn't work to protect consumers. The MHRA responds by repeatedly claiming consumers are dying by suicide because of mental health challenges. They will further stress that patients should continue taking their prescriptions and talk to their doctors if new or worsening symptoms occur.

And so it is: The MHRA's new Twitter campaign promotes consumers as guinea pigs on a dizzying carousel ride. Round and round we go on a cheap carnival ride with faulty rivets and a drunken operator. Similar to the banking industry responsible for the financial demise of countless hardworking citizens, the MHRA knows there's a systemic problem and that it is the public who will pay the price for MHRA's willful indifference to critical drug safety.

Just as the banks sold dodgy mortgages, the MHRA peddle dodgy promises to further the myth that they exist to promote health and safety. In truth, they don't. Their protocol for managing dangerous drugs will always benefit the pharmaceutical companies who pay their wages. The MHRA is fully-funded by the industry who make the products noted in Yellow Card reports. Hence, the MHRA won't follow up Yellow Card reports.

MHRA's new tagline should be "correlation does not equal causation." At least this would help alert unsuspecting consumers that with MHRA at the helm, there is grave danger.

I've been banging the drum about this problem for years. Here's a recent Podcast I did that highlights this.



Bob Fiddaman


MHRA 'Yellow Card' Related

My Meeting With The MHRA - (PDF) September 2, 2008

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I - November 26, 2011

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip" - November 27, 2011

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine - November 28, 2011

MHRA In Buck-Passing Specialist Cahoots - December 07, 2011

MHRA: Follow-Up Rate at a Price - September 29, 2015

MHRA: "We Now Consider This Request Closed" - October 20, 2015

The Mechanics of the MHRA - December 03, 2016

SSRI Deaths in Clinical Trials - May 05, 2017

MHRA Seek Payment For Info on Deadly Drugs - June 05, 2017

MHRA: No Deaths in Pediatric Trials, But What About Adults? - July 17, 2017

Danny Lee-Frost of the MHRA - July 20, 2017


EXCLUSIVE: MHRA Asked Sky News to Remove Antidepressant Reference - July 25, 2017






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