Public Citizen Criticizes FDA’s Draft Guidelines on Drug Risk Disclosures

Rob Wipond

In the wake of a major court decision, the US Food and Drug Administration has issued new guidelines for public comment, covering how pharmaceutical companies present drug risks to doctors. In a freely-distributed commentary published in JAMA Internal Medicine, Public Citizen’s Sidney Wolfe writes that the FDA “has now tilted toward protecting industry’s commercial speech and away from protecting patients from the risks of prescription drugs and biological products.”

The new draft guidelines state that “FDA does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling, and is distributed by a firm in the form of a reprint or digital copy of a published study, if the study or analysis and the manner of distribution meet the principles set out below…”

Those principles, writes Wolfe, give too much leeway to pharmaceutical companies. “When evidence supports a reduction in the risk associated with the use of a prescription drug or biological product, the manufacturer should send the evidence to the FDA, state the basis for the reduction in risk, and request a labeling change,” writes Wolfe. “The draft guidance, however, may encourage companies to promote the supposed evidence of lower risk in a peer-reviewed article directly to physicians, without the FDA ever having been informed[.]”

Wolfe writes that the draft guidance “has the potential to undermine the FDA’s drug safety laws and regulations and should be changed.” The FDA is accepting public comments on the guidelines until August 25, 2014.

Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products: Misguided Approach (Wolfe, Sidney M. JAMA Intern Med. Published online August 15, 2014. doi:10.1001/jamainternmed.2014.4547)

Guidance for Industry Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (U.S. Department of Health and Human Services Food and Drug Administration, June 2014) (For electronic comment submissions.)

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Rob Wipond
Rob Wipond is a Victoria, British Columbia-based freelance journalist who has been writing on mental health issues for fifteen years. His research has particularly focused on the interfaces between psychiatry, the justice system, and civil rights. His articles have been nominated for three Canadian National Magazine Awards, six Western Magazine Awards, and four Jack Webster Awards for journalism. He can be contacted through his website.

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  1. In We Become Silent the documentary on the multiyear war against health freedom John Hammell can be heard at a Codex meeting speaking to a USA representative there – who is intent on not having the words and intentions of the United States people and the United States Congress represented. Which is in keeping with the intent of Codex Alimentarius, NAFTA and CAFTA which seek to cede National and citizen representation and rights to international bodies and corporations.

    We Become Silent The Last Days of Health Freedom

    The Magazine Townsend Family Letter to Doctors and Patients has an article by their Marcus A Cohen, M.D. on the ongoing attack on progressive, functional, restorative Medicine.
    What’s in a name? Terming non-standard medical treatment.(Townsend’s New York Observer)

    Andrew Saul writes how the biochemical treatment M.D.s do not have anything from their Journal that is Medline listed:

    Psychiatry Abram Hoffer, M.D., Ph.D. in the history of the Journal explains how it became apparent to the leaders in biochemical therapies in Psychiatry that nothing they did could be published and so they needed to create their own Journal in 1967 (13 years before DSM-3 came out making everything “Medical model” entailing “imbalances” that need to be “treated” (IE, with expensive Patent drugs exclusively).

    What is happening now which is the same as has been happening — companies are writing the “information” and the “history” of what happened, and those who would write the truth are having steps taken against them by the stratagems, the manipulations of corporate operatives.

    One key concept is that people should have nutrients to protect against specific drug harms and depletion. Though one is hard pressed to find references to that made by NARPA, Robert Whitaker, National Empowerment Center, Joanna Moncrieff, M.D., Critical Psychiatry or Peter Breggin, M.D. ! Let alone of course DJ Jaffe, MD or E Fuller Torrey, MD Joseph Biederman, MD, Charles Nemeroff, MD, the APA or NIMH.

    Who cares about information of importance? It has to jibe with the party line, and those affected are not invited to that. If they were before, then we will exclude them soon.

    Nutritional Treatment of Tardive Dyskinesia
    by Walter Lemmo, ND

    Charles Gant of course, Safe Harbor
    Nutritional Protection from the
    Damaging Effects of Psychiatric Drugs

    Hyla Cass, M.D. Nutrient Depletion

    We Become Silent. Stand Up.

    Dan Burdick Oregon, USA

  2. FDA is becoming more of a laughing stock – which is no laughing matter to anyone seeking medical treatment in this day and age since the snake oil is back and the agency responsible for keeping it off the market has sold itself to the companies.

  3. Btw, does anyone also think that a ban on publically criticising drugs and treatments or discussing their efficiency/side effects is on its way? As “unauthorized dissemination of misinformation leading to public health hazard” or something of that sort?

  4. A ban on publicly criticizing drugs, and what constitutes a ban.

    Natasha Campbell-McBride criticizes drugs from the standpoint of, and in the context of, being extremely knowledgeable on gut and immune system Medical information. She explains how they destroyed the career of Andrew Wakefield, M.D. — He was not even listed as one of the main authors, he just did the intestinal biopsy that found the live microorganisms from the vaccine that had been administered.

    Natasha Campbell GAPS Diet
    Weston A. Price Foundation Lecture 2011

    Do You Hear The Silence Again? BMJ admits fraud claim against Andrew Wakefield has no basis in fact. Dr. Andrew Wakefield’s work being proven once again in a court of law to solidify the very real connection between autism and vaccines.

    Neurosurgeon Natasha being not “Critical Psychiatry” nor a “Psychosocial Theorist” she probably will not be included into the rhetoric and deliberations of adherents to that camp of evidently restricted scholarship. Then the information will be controlled and attacked by strategic campaigns in USA public health policy venues and the USA press. In toto, this constitutes ban.

    Natural News states that public media such as FaceBook is being obviously censored:

    Truth seekers rushing to Diaspora and to escape censorship of corporate-run social media
    By Mike Adams August 17, 2014

    Immediately after the 2013 ALTERNATIVES Conference where Eva Edelman had a workshop
    an well formulated attack on health and personal liberty commenced involving DJ Jaffe, E Fuller Torrey, and Congressman Tim Burton. (Citizens of all ages in the USA need to be screened, they tell us, screened for pre-crime and thought crime by trustworthy expert authorities, and receive any ordered treatment the authority figures specify. In this way they tell us we will all be safe, and people will not be homeless. People “have”” serious” or “severe””mental illness” and this must be detected and treated — most especially with people who do not want whatever they authority tells them must be their treatment — such people “have” “an-o-sog-nosia” (big word, don’t know if I can pronounce it…), as they tell us. Groups such as the NEC and SAMHSA should be controlled and defunded because their programs divert funds from getting USA citizens screened and drugged, and their words send out publicly misguiding criticizing ideas about drugs and the expert authorities.

    Robert Whitaker first accepted as speaker at the so-named ALTERNATIVES Conference, then blocked, and then accepted again with a rebuttal keynote speaker unlike ever happened before:

    The Alternatives Conference, and the Story of an Opportunity Lost
    The Medication Taboo in the Land of Free Speech
    Published on October 6, 2010 by Robert Whitaker in Mad in America

    Thomas Szasz
    “Torrey’s remedy for the problem of people being at liberty to commit crimes and suffer the consequences is intensifying the traditional legal-psychiatric practice of incarcerating innocent individuals and calling it “hospitalization” and “treatment” and even “suicide and crime prevention”: “The solution to this situation is obvious — make sure individuals with serious mental illnesses are receiving treatment.”

    Natasha Campbell-McBride

    “So if the child is damaged enough, the vaccine can provide that last straw.”

    Gut Psychology Syndrome GAPS Talk by Natasha Campbell-McBride

    50:10 —

    “A precious time wasted when the child could have been treated”

    “Which means that those toxins had enough time to bombard the brain. and to cause organic damage in the brain.”

    “When we do scanning — there’s a very sophisticated scan called PET Scan — when we do PET Scan on severely autistic children of the age of 3 to 5, we find perfectly normal brain.”

    “These children are born with perfectly normal brains.”

    “But when we do the same scan

    “To reverse this is much harder.”

    “When these children grow up — GAPS doesn’t disappear, unless it hasn’t been treated.”

    “And, then they get to teenage years, and the young adulthood — and substance abuse is one of the venues these children usually take.”

    “You know that about ten years ago, British Government pronounced cannabis to be a less damaging substance — and so it became more available to our youngsters.”

    And Psychiatrists began ringing the bell, and they still ringing the bell, and it doesn’t seem to make any difference, that they seeing growing numbers of youngsters develop first episode of psychosis, after the first use of cannabis.”

    “These are GAPS children.”

    “I’m sure you all know teenagers who go to parties, smoke cannabis, and they’re fine.”

    “But these are GAPS children. They’re vulnerable.”

    “Cannabis can start a psychotic episode, in these children, and that then leads to diagnosis of schizophrenia, being sectioned, being put on very potent medication – and that’s a slippery slide – for the rest of your life.”

    “Once you get hooked on those medications, it is very difficult to get off those things.”

  5. Also today, “Demand labeling on GMO foods.” The ban on the telling of the truth in this case takes the form of a well funded, strategic attack on the USA citizens moving to have truthful labels be on GMO foods.

    “Need to counteract our opponents’ disinformation campaign”

    “We’ve seen this playbook before – a big buy (of expensive media propaganda) followed by a relentless stream of misleading attacks that confuse voters and erode support for GMO labeling.

    Front groups funded by (large corporations) are already pumping out disinformation-stuffed statements about why we’re better off not knowing what’s in our food. ”

    Yes on Measure 92 – Oregon Right to Know.

  6. I am concerned to see an individual making false statements, claiming:

    “BMJ admits fraud claim against Andrew Wakefield has no basis in fact. Dr. Andrew Wakefield’s work being proven once again in a court of law to solidify the very real connection between autism and vaccines.”

    As the journalist working on the BMJ’s Wakefield investigation, I can assure you that the journal stands wholly behind its findings with regard to Wakefield and has at no time ever “admits fraud claim against Andrew Wakefield has no basis in fact”.

    Nor is it true that his work is being “proven once again in a court of law”. The US court of federal claims vaccine division had lengthy trials of Wakefield’s theories and conclusively, and scathingly rejected them.

    Anyone who believes that the case against Wakefield is weak might want to read the longest account yet of my findings against him, set out on penalty of perjury. If you have a genuine interest, read this material and come to your own conclusion.