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FDA and Quran Burning: Trouble Can Start With a Tweet

Bravo! Florida Pastor Terry Jones has decided not to burn a copy of the Quran. The next danger is that the Pastor’s “success” will be seen narrowly as the unique confluence of 9/11, the Ground Zero mosque, and the readiness of millions to take to the streets at signs of American intolerance toward Muslims.

FDA Matters thinks the lessons are larger and urges FDA to pay attention to how this reflects changes in the way crises develop and decisions are made.

According to the Washington Post, on July 12 the Pastor sent a simple message on Twitter: “9/11/2010 Int Burn a Koran Day.” From that beginning, he became the focus of international concern and one of the most watched people on the planet. All news sources—print, television and internet—were filled with stories about his intended actions. The situation most resembled a dramatic, high-stakes hostage negotiation. In a sense, it was, with Pastor Jones’copy of the Quran as hostage.

If we are imaginative, there is much more to concern us than Pastor Jones. We now know that one man’s temper tantrum (or cause?)—distributed via Internet, Twitter, YouTube, 24/7 news outlets, etc.—can leave the world’s leaders pleading for a favorable outcome. The power to capture the public eye, move public sentiment and galvanize the world…now belongs to all us. As Pastor Jones demonstrated, not everyone has the restraint to use that power responsibly.

In the late 1980’s, AIDS activists staged a large demonstration that caused a multi-day lock-down situation at FDA. Patients and their friends were expressing their desperate need for access to drugs in development. It was a scary time at the FDA. No one wanted to create the precedent that FDA “would bend to a mob,” but there also was a lot of sympathy for the plight of HIV patients.

Soon thereafter and over the next few years, FDA made a number of significant changes to the drug approval process. For example, the demonstrations eventually led to an accelerated approval process and “fast-tracking” of certain new drug applications. FDA began to treat surrogate endpoints seriously (e.g. CD4 viral load count rather than HIV disease progression). Most of these changes have been judged “good” with the passage of time, but there was a lot of uncertainty at the time.

With all the new avenues for communication, this scenario could easily repeat itself today on behalf of any number of diseases that are life-threatening or crippling. Could a group of parents with dying children try to force FDA to grant compassionate use access to a drug in pre-clinical (animal) testing? To make their point, the parents could create a vigil for the children with countdown clocks, while posting daily video showing their deterioration.

Yet another scenario might blend the skills of the Tylenol poisoner with the long-term persistence of the Unabomber. Every three months, anonymous videos might be posted that show gloved hands adulterating some additional batches of a food, drug or device. This would be a corporate nightmare that would also bring all FDA-regulated products under suspicion. FDA would be at the center of an enormous public health crisis.

I know I have not reflected the depth or breadth of challenges FDA could face. Hopefully, these few make the point that FDA is increasingly vulnerable as an agency. It must prepare for risks well beyond those faced by most federal agencies.

Commissioner Hamburg ought to meet soon with senior staff to review, extend, and refresh FDA’s crisis plans. Even if they met two weeks ago, they should do it again because Pastor Jones has proven that the world has changed.

And while senior staff is having this discussion, they should also plan some simulations and practice drills. A crisis plan is only as good as the ability to implement it.


The Washington Post story describing the escalation after the tweet is at: http://www.washingtonpost.com/wp-dyn/content/article/2010/09/10/AR2010091007033.html?hpid=topnews

One Response to “FDA and Quran Burning: Trouble Can Start With a Tweet”

  1. I received two comments that my theme, relating Quran-burning and FDA crisis management, is “bizarre.” I think it is from people who read the headline or the first two paragraphs and not the entire column. In any case, I recommend Michael Gerson’s column in the Washington Post today (September 14). http://www.washingtonpost.com/wp-dyn/content/article/2010/09/13/AR2010091305289.html?hpid=opinionsbox1.

    Looking at the situation far more generally, he observes: “In the Internet era, attention for stupidity is a democratic right, rewarded for audacity and timing alone. The new media provide a platform without filters for those without credentials — people who, in previous times, could not get a letter to the editor published in the shopper’s gazette.” As I have suggested, this same empowerment is now potentially available for people who want FDA to act (or not act) in particular ways.

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