Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Don't Blame Canada: FDA Can't See Drug Risks in Its Own Database!

Don't Blame Canada: FDA Can't See Drug Risks in Its Own Database! | Pharmaguy's Insights Into Drug Industry News |
It’s become clear recently that another thing Canada does better than us here in the U.S. is drug safety. A systemic change needs to happen in the U.S.

We first noticed this when we began our work in 2011 to optimize the FDA’s Adverse Event Reporting System (FAERS). As we’ve documented numerous times, raw FAERS data is a real nightmare and nearly impossible for everyday citizens to use, search, and draw meaningful value from. About a year ago FDA launched OpenFDA to make these data a little more accessible, but there are still a number of issues.

By contrast, the Canadian health authorities maintain a simple, easy to use, searchableonline database of drug adverse events reported in Canada.   It’s nothing too fancy, just what you’d expect from a modern online search tool – with data properly mapped and optimized, very recently updated, and immediately accessible.

You know, all the things that FDA somehow isn’t able to do with FAERS.

With these data more readily accessible and available, the Canadian authorities are able to better monitor for drug safety issues. For example, an article in the Globe & Maillast week detailed Canada’s plan to add a suicide label warning on ADHD drugs.

In our analysis of data from FDA’s FAERS database, we see active safety signals on all of the main ADHD drugs for a number of suicide risks (meaning that the reported rate of these adverse events is a lot higher than we’d otherwise expect) and yet no such label changes have been warned or issued in the U.S.

Why? It’s not hard to assume that it has something to do with FDA’s inability to properly access their own FAERS data and identify these risks. We can see them, so why can’t they?

Pharma Guy's insight:

Speaking of ADHD drugs such as Adderall, you might be interested in how this drug is promoted to US citizens using celebrities and even children of celebrities.

Pharma marketers are capitalizing on the e-Patient movement by leveraging social media, online video, and real patient stories in an effort to become more "patient centric" (see, for example, "Patient Story-telling Marketing"). Add a celebrity spokesperson who is also a patient or a caretaker of a patient and you've got gold!

But in some cases, this practice may be going too far. This article asks the question: Can anecdotal "evidence"/experiences mentioned in patient videos -- even unbranded videos -- cause unnecessary visits to the doctor's office and over prescribing of drugs with serious side effects? 

Read the full article here: 

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‘Prescription Thugs’: Tribeca Review

‘Prescription Thugs’: Tribeca Review | Pharmaguy's Insights Into Drug Industry News |

Thugs offers a damning summary of the FDA approval process as a closed loop in which one hand washes the other and crucial data can remain hidden. With its reference to ghost-written “expert” articles, the film touches upon territory covered in depth in the recent documentary Merchants of Doubt. And there are startling statistics: Someone dies from an accidental overdose every 19 minutes; oxycodone revenue plunged 80% after its crushable — i.e., easily abusable — form was discontinued.

Bell and Alexander have compiled an introduction to a huge subject, hitting on many of its facets without the time to delve deeply. But they make their points about the toxicity of drugs, the moneymaking machinery that drives their overuse, and the relative safety of alternative options like homeopathy. Psychiatrist David Healy, a pharma gadfly, weighs in, as does reformed Big Pharma sales repGwen Olsen, full of an insider’s fury. Richard Taite, director of the Cliffside Malibu rehab facility, takes a more distanced stance. Like Bell, but less naïve, he’s interested in the quick-fix culture of addiction.

At its most trenchant, Thugs suggests that the very definition of quackery needs to be reexamined, along with the supposed legitimacy of legal drugs, licensed physicians and pharmaceutical manufacturers. In its wide-ranging examination, the film excels at placing demonized street drugs and medically dispensed pharmaceuticals on a continuum. Coming at the subject from a variety of angles, Bell and his interviewees make clear that Adderall, Ritalin and OxyContin are variations on meth and heroin — neatly packaged and never targeted by the so-called war on drugs.

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