FDA Proposal Should Anger FQ Community

The recent proposal by the FDA to allow pharmaceutical companies to choose their own language Man Kicking FDAdescribing drug dangers should outrage and disgust the Fluoroquinolone (FQ) community. This new proposal would allow pharmaceutical companies to provide doctors, hospitals, and end users with crafted information that conflicts with actual reports that were developed via scientific process, a process that is already rife with bias.

Needless to say the proposal was supported by many pharmaceutical companies including GlaxoSmithKline Inc., Allergan Inc., Amgen Inc., Pfizer Inc. and others. These companies argued that they basically have a first amendment right to distribute the literature they want.

The FDA said it would allow distribution of new information published in medical journals showing that the severity or rate of a side effect is lower than described on the product label. The new data could even “call into question a causal relationship between a drug and an event in the approved labeling.”

Here’s the problem, under the new proposed guidelines pharmaceutical companies can pick and choose what research they want to tell end users about. Results from individual studies into the adverse reactions caused by pharmaceuticals can vary widely. The reason for this, in my opinion, is that many of the drug company funded studies are usually less critical than that of independent peer reviewed studies. Under the new proposals, the companies select and choose what data they want to present to the end user, whether they be a doctor or a patient.

Sidney M. Wolfe, founder of the Public Citizen’s Health Research Group wrote in regards to this proposal, “Its main supporters are drug companies and their associations, all of which would benefit from being allowed and encouraged to sell more drugs by making them seem safer than FDA has judged them to be.” We already know, from our experience, the FDA’s standards are actually too lax.

In the FDA’s own words they would not “object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling.” This is shocking!

Why now? I have two theories.

First, in light of all the negative media attention regarding FQ’s and other pharmaceuticals the pharmaceutical companies want to lessen warnings and make their products more palatable and thereby increase sales.

Second, it is no secret that pharmaceutical companies want into ‘health space’ (the chunk of cyberspace devoted to health related issues) where we, as an FQ community, exists. So through intermediate companies like WEGO Health (run by pharma executives), and others, they can distribute their new, more palatable, versions of their drug literature into health space. WEGO Health is using their health activists, who according to WEGO Health’s own polls want pharma regulating the data in health space (1), to shape public opinion regarding pharmaceutical companies and their products (stayed tuned to MyQuinStory for more articles on this tactic in the near future).

Why Should This Anger the FQ Community?

Currently we represent a thorn in the side to the pharmaceutical companies. They are seeking to negate that thorn. At a time when we are trying to draw attention to the severe permanent disabling adverse effects suffered by thousands due to the Fluoroquinolones, this proposal would restrict dissemination of data about the drugs to information sanctioned by the company itself.

Peter Whoriskey writing for the Washington Post states, “Under the proposal a drug-maker could present evidence that the severity or frequency of a side effect is less than what is suggested by the FDA-approved label. Or it could question whether the drug causes the side effect at all.

As mentioned earlier, under these new proposals new re-interpreted data could be used to call into question a causal relationship between a drug and an event. In other words, the adverse events we as a community describe regarding FQs, could be dismissed more easily.

Sound too familiar?

FDA requested public comments which Public Citizen obtained under an open records request. Roughly FDA Fail99 percent of those comments were negative.

One commentator wrote, “drug reps stretch the truth more than enough.” Yet another asked: “How can this be considered in any way? Where I come from you do not let the fox in the hen house.

The fox is constantly trying to get into our hen house to control the data we read, control our narrative, and control our perceptions and the FDA is allowing this to happen. If we do not support Public Citizen’s request for the FDA to withdraw the proposal, this reality could be sooner than later.

Update: The FDA is still accepting comments on the actual guidance as required by law. We can all COMMENT NOW! Simply follow this link:
http://www.regulations.gov/#!docketDetail;D=FDA-2014-D-0758
and then the blue Comment Now! link.
  Please take the time and leave your comments!

#FDAFail

Sources:

Reuters

Washington Post

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David experienced an adverse event to the the fluoroquinolone Levaquin in 2007 at age 46. Prior to, he was a healthy law enforcement official. Now, disabled with drug induced mitochondrial disease/dysfunction, he is an FQ patient safety advocate, citizen scientist, FQ researcher, author, and commentator. He has contributed to case studies and published academic papers on the FQ’s in the BMJ, European Journal of Medicine, The Journal of Community and Supportive Oncology, Oxford Academic Clinical infectious Diseases, and contributed data to many more outlets.

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