How the FDA Manipulates the Media
scientificamerican.com
scientificamerican.com
From the article: "Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story. At the same time, the FDA cultivates a coterie of journalists whom it keeps in line with threats. And the agency has made it a practice to demand total control over whom reporters can and can't talk to until after the news has broken, deaf to protests by journalistic associations and media ethicists and in violation of its own written policies."
So let see if I understand this...
1- They tell their friendly reporters who they can and can't talk to with conditional embargos.
2- They don't let reports they view as hostile into the press releases.
3- They actively thwart these reporters viewed as hostiles by intentionally telling them lies and half-truths.
This is completely absurd, A federal agency is manipulating the story it wants and the side it wants to tell it. It is picking the winners and losers, and the winners keep quiet about the scam because it they start to be seen as trouble makers, soon they will start getting the Fox News treatment too.
When, for any given thing you want to regulate, there are 4 incredibly wealthy special interest groups trying to warp your message to protect the profit margins of the companies they represent, rather than keep safety or anything else in mind there, making sure that you don't take "Totally reasonable measure A" and get the people you're protecting messaged, "HOW DARE YOU, MY FREEEEDOM!" - that's quite difficult.
But despite my understanding of that, the HUGE problem there is that "Totally reasonable measure A" and "Draconian Evil Measure X" look almost exactly the same to us onlookers, and when the FDA, or anyone, uses "Morally Ambiguous Embargo Y" to protect their actions, why, the rational response from us as onlookers is the ASSUME that they're performing "Draconian Evil Measure X."
So what, exactly, is the answer? I don't think there IS one presently out there that isn't incredibly messy, but I hope we can still discover it - that is, figure out how to protect the almost certainly true and reasonable actions from the 'bad guys,' while not falling afoul of the rational reaction of the 'good guys' (us, in this case, the people being protected) and coming under attack from THEM.
Right, but see you shouldn't because that's hilariously naive.
He's demanding transparency and good faith from the FDA.
Maybe it's better if I put it this way, "I don't actually think the FDA is up to rotten fuckery here, but it sure as hell looks like they're being FUCKING EVIL, and without a method to for to tell that they aren't, they should FUCKING STOP IT."
Is seems to be the same move as using rebate coupons rather than outright sales.
If so, I'm afraid you'll be sorely dissapointed.
Preferential reporters by government agencies ought to be illegal.
Why must the pharma company answer solely to shareholders? They are doing medicine - they also have an obligation to do right by the public. Generally, when a medical professional fails to do right by the public, they get replaced with one that will.
For many medicines, I have absolutely zero choice in that relationship. It's <Company> selling <Drug that I need to not die>, or the highway (Not to mention that I'm not choosing the medicine - my doctor is prescribing it.). If that is choice, then so is not paying taxes.
To be consistent with your position, preferential reporting by anyone with an involuntary relationship with their 'customer' base should be illegal. This would disqualify most pharma companies right off the bat.
If you're talking about pharmaceutical companies, the FDA has enormous power over them, and I don't remember them ever saying anything critical of the FDA. That would be taking enormous risks.
Not that I pay close attention. There might be some, but I think the pharma industry is deathly afraid of antagonizing their regulator.
The propagation of (ethically-compromised) dysfunction? An escalating "giving forward" of negative value and technical debt? I seem to be increasingly noticing it.
Where a well-intentioned rational actor, because of upstream ethically-problematic dysfunction, chooses a "least-bad option" of creating their own ethically-questionable dysfunction, which then has a similar effect on downstream actors. Where at any point, you could imagine an upstream channel with a "no, that's beyond the pale, you need to stop doing that", but because of noise or other things, such signalling isn't working. Until it does. Sometimes.
In this case, company and press lying, tolerated by press and public, prompts government conduct that further degrades the press, increases tolerance of lying, and impairs everyone's ability to improve government conduct.
Or consider the attempt to force TPP ratification in post-election session. The Obama administration has only managed to remain kind of functional, by doing end-runs around a dysfunctional legislature and press. But that has a side-effect of disabling legislative and journalistic checks on groupthink and regulatory capture. And press discourse has become loud and low quality, drowning out signals. So while a (now former) White House official, nicely characterized the regulatory capture of US copyright law, as "extremists are people who talk only among themselves", with only our current functionally-degraded mechanisms, it's a struggle for that insight to constrain policy.
The larger context might be a decline of civic society and civil discourse. But this seems a particular feedback pattern, of "things are bad, so now I have to make them worse". But does it have a label?
Everything makes more sense if you don't think of the media as a medium, but a group of self-interested actors who sell tickets to exposing or suppressing what gets published.
For illustration. Science education is remarkably ineffective, K-14, and worldwide. A rule of thumb that "people don't care whether science education actually works", will rarely steer you wrong. But it is an almost useless description of the underlying tangle of incentives and capabilities and visibilities and costs, which cause that surface behavior.
Take a professor teaching cell biology, who isn't disinterested in teaching deep understanding, but who, given severe time constraints, isn't going to disservice their students by trading against a specific superficial understanding that the high-stakes med school MCAT exam tests for. So yes, "don't care", sort of. But change the MCAT, and suddenly...
So one can have a observationally good description, one that's fine for spectators, but which isn't illuminating or helpful interventionally.
Or take the earlier copyright example. During the fight over SOPA, Hollywood executives publicly and angrily complained about congressmen not staying bought. A surface reading of that isn't a bad description of everyone's behavior. But my understanding is, they were basically saying "we talk among ourselves all the time; and we all agree; only a few weird and confused others disagree; and we're now startled and dismayed to find some politicians disagreeing; and can only imagine that this results from them being bought, or lied to, likely by the tech industry; we payed good money to elect what we thought were good people - why should we pay for the reelection of the corrupt and the gullible?". Will more insight into mechanism help you? Maybe not.
But while incentives matter, it's the actual incentives that matter. What if US copyright extensions were fought not with "Constitutional intent" and "public interest", so basically "we want you to give up a few billion dollars a year in Pooh et al merchandising fees", but fought instead with "here's a change in trademark law, or a copyright-excepting guardianship of a national treasure, which will preserve your big revenue streams in perpetuity". Addressing actual incentives, rather than narratives.
It doesn't really matter what the initial justification was, it is what it is. You're increasingly noticing it because it is occurring everywhere and without any negative consequences to the bad actors (quite the opposite: significant rewards.)
More funds for checks and balance. Laws that make it clear what transparency means and actual funds for enforcing these laws.
In general the US seems to be stuck in a gordian self-fulfilling prophecy: many people in the US see government administrations evil or inefficient in all matters and they are enough to actually handicap the government administrations, and make them actually inefficient.
I think that at one point US citizens have to come to terms with the idea that they need to be protected by efficient government administrations, and that regulations are actually what makes free market move in the direction of social progress.
But seeing the resistance there was to Obamacare (which, seen from western Europe is really the bare minimum a civilized country should have) I am not holding my breath.
Hmm...
http://www.newyorker.com/magazine/2011/11/14/the-tweaker
(Suroweicki and Gladwell are two of favorite authors on their staff right now.)
http://slatestarcodex.com/2016/09/13/some-context-for-that-n...
"In any case, claims that the sugar industry sponsored one study back in the 1960s, and this means everything we’ve ever thought is wrong and biased against fat and in favor of sugar, miss the point (especially since there are probably problems with both sugar and fat). Whatever study the New York Times has dredged up was one volley in an eternal clandestine war of Big Fat against Big Sugar, and figuring out who’s distorted the science more is the sort of project that’s going to take more than one article."
The result is that the American media basically has become Pravda when it comes to the federal government.
FIFY.
And why are you limiting this to the feds? State/local actors are frequently worse. Or at least, I haven't heard of the FDA arresting journos.
From a science (and future funding) perspective, large collaborations with important results are interested in making a splash (which, referenced in the article, backfired for BICEP). They're interested in quality reporting, but they want to have the opportunity to bring the discovery (think Higgs, gravitational waves, etc.) to the world.
Science stories are hard to report, as the journalist, even one with a science background, needs to come quickly up to speed with a nuanced field.
What's the best way to ensure that a science story can be reported well, as argued for in this article, without the embargo getting jumped?
"Hello, Dr. Not-in-ATLAS/CMS physicist, we've never met before, but I work for the NYT and I'm working on a story appearing Thursday, around the same time as the CERN press conference. If both experiments had observed a single Higgs at 125 GeV mass, what would it mean? Interesting. Also, please don't tell anyone."
Such an embargo would last only tens of seconds after the physicist hung up the phone (and for good reason, as free exchange of information is paramount in academia).
How would you like to see scientists report results? Would you prefer that researchers present results to an unprepared press at the same time as the journal article appears, with improved reporting a week later, or get informed but embargoed reporting at the same time as the announcement?
– Refuse gifts, favors, fees, free travel and special treatment, and avoid political and other outside activities that may compromise integrity or impartiality, or may damage credibility.
– Deny favored treatment to advertisers, donors or any other special interests, and resist internal and external pressure to influence coverage.
– Explain ethical choices and processes to audiences. Encourage a civil dialogue with the public about journalistic practices, coverage and news content.
– Expose unethical conduct in journalism, including within their organizations.
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TechCrunch said in 2008 that they will break every embargo they agree to.[2]
Edit: they later (2011, 2012) backed down from that pledge. See CobrastanJorji's comment below (thank you!)
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The Society of American Business Editors and Writers argue that they are useful to keep the standard of journalism high, but that "journalists are ultimately responsible to the public."[3]
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And just for fun, and to make matters more concrete, here's a Slate article in which an example (an article published by the WaPo) is raised that calls the embargo system into question.[4]
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[1]: http://www.spj.org/ethicscode.asp
[2]: https://techcrunch.com/2008/12/17/death-to-the-embargo/
[3]: https://sabew.org/2012/05/the-embargo-and-business-journalis...
[4]: http://www.slate.com/articles/news_and_politics/press_box/20...
I hope this can help answer your question.
See https://techcrunch.com/2011/12/05/going-too-far-the-techcrun... -> "Do we break embargoes? Sometimes. Do we break embargoes even after agreeing to them? Sometimes (but very rarely). Do we agree to embargoes and then respect them? Sometimes."
or https://techcrunch.com/2012/08/24/the-lyft-launch-that-could... -> "For the most part, though, all the TechCrunch writers are cool with embargoes. I don’t know a single person here who doesn’t accept them and we generally all play by the rules."
That second article is a good example of another problem with close-hold embargoes. You might wonder "why not just wait until the embargo lifts, then interview someone, then publish?" This article shows a reporter who decides that they couldn't possibly be reduced to posting an article about something another reporter posted about twelve hours previously.
The other part: FDA is controlled by the companies that come under its umbrella. Think of the fox guarding the hen house.
So in the final analysis, those companies control the media. But it gets better; sometimes, the parent company of a media company is in some sort of partnership with the companies that control the FDA.
The main example that broke the news about this was when the FDA announced regulations about e-cigarettes. The tobacco interests were staunchly opposed to the regulations, and the FDA wanted to prevent NPR + other journalists from getting comment from them.
Try to actually read before injecting your politics.
So the interested media (who cover tobacco legislation) were kept out. So... The companies pulling the strings of the FDA were able to control the messaging of the ruling to make it about "we're in support of this" rather than "we're removing all our competition by employing the FDA as our market enforcer"
The FDA definitely seems to be controlled by the pharmaceutical industry. I guess sometimes these industries step on each others toes getting things done, and in the e-cig case pharma won over tobacco.
P.s. friendly note that your first sentence is against HN rules.
How the FDA operates, or how it is operated, is no news for those who have been following the FDA. So the e-cig regulation was no news.
I wish how food companies where allowed to market a particular type of cereal as good for you made the breaking news reel.
And before you say there's solid science behind it, wasn't there an article the other day about how food companies control(led) food and nutritional scientists?
I always try to look at the big picture, not just a breaking news item.
People who work at companies that come under its umbrella wish that were true. It's not. There is a revolving door and a lot of pressure back and forth but the relationship is a lot more complicated than "pharma owns the FDA". There are some fire-breathing regulators there (who think they're the only thing preventing Big Pharma from selling us poison) who would slap your face if you told them that.
The idea here is that small, powerful parts of BIG pharma do functionally control the FDA, and they use the FDA to manipulate the market in their favor - and to the detriment of all smaller players in that space. The fire-breathing regulators out there, they're useful idiots in that battle - convince them of some threat, and like an attack dog, they'll go after it. That wouldn't be so bad, but it's just that some players in big pharma are holding the leash and dictating (or at least strongly influencing) which targets to hit and how to hit them.
(edit: I don't mean to say that some people who work under the FDA's oversight don't feel like you said in your comment, but I'm asserting that in my experience, we feel somewhat differently than that - I felt I should clarify, because you may work there yourself, and the way I put it up above, I sort of excluded the possibility of anyone feeling that way. It's not that I don't disagree with you here, it's that I don't mean to disagree disagreeably. :) )
I'm sure there are some people at the FDA that believe they are still doing a good job by preventing bad drugs. But even there they kill far more people than they save by preventing life saving drugs from reaching terminally ill patients, and vastly increasing the cost of producing drugs. They need to be shut down.
I also recently read The Right to Try about how the FDA delays the approval of drugs for terminal diseases costing countless lives. This is less statistics based, but it shows many absurd decisions by the FDA. Terminally ill people are more than happy to take risks for drugs even if there is a small chance of them working.
The FDA delays approval of drugs even when they are known to be safe, because they haven't yet proven efficacy, which is just silly. In one case they wouldn't approve a drug because they demanded a clinical trial larger than the number of patients that existed with that disease, and way larger than necessary to establish statistical significance.
They ignore data from previous studies and from other countries. So there are cancer drugs that are known to be very effective and have been used for decades in Europe, but still aren't approved in the US. The death toll of this decision alone is enormous. Thousands of people could have been saved if this treatment was allowed in the US, but we are stuck with much less effective, older treatments.
The Slate Star Codex article fails to make the case that lowering the general regulatory thresholds for medical devices or drugs improves societal outcomes. It makes a compelling, if possibly flawed, case for the EpiPen, but assumes generalizability rather than showing it.
We know the costs of not having something like the FDA. All one has to do is look at the supplements industry and imagine if real drugs were like that.
Oh, you thought you were getting what was on the label? Silly you. https://healthyfoodusa.com/fda-finds-majority-of-herbal-supp...
You thought you'd get something that would help? Silly you. http://www.health.harvard.edu/staying-healthy/dietary-supple...
You thought you'd get something that didn't have major unknown side effects? Silly you. http://emedicine.medscape.com/article/817427-overview
Edit:
Also ignored is how the FDA is a major incentive to create something new that both helps with the problem and doesn't generate an unreasonable amount of other ones. If the barriers to market entry are removed, you are putting the informational cost on the consumer. If it's cheaper to fool them than to do the due diligence in development, that's what will be done. And it's pretty clear from the supplement industry that it is cheaper.
Scott Alexander likes to make the future costs of a lack of new medications argument a lot. He has to account for the costs of a lack of new effective medications as well.
Edit 2:
Scott Alexander doesn't try to make the case the FDA is corrupt. He talks about how Mylan uses the court system and lobbies congress. And his point about costs is undercut by a later post he made about coming up with the chairs statistic: http://slatestarcodex.com/2016/08/31/terrorists-vs-chairs-an...
Ideally I would like the FDA to be replaced by a more efficient regulatory agency. Europe's system seems to work a bit better. I dream of something like prediction markets, where people could bet on what medicines would work and not work. At the very least, some system designed to make regulators accountable for lives cost due to not approving drugs, just as much as they are accountable for approving bad drugs. Both sides of the tradeoff need to be explicitly acknowledged.
But I'm not confident that nothing at all would be worse than what we have now. Snake oil wouldn't be legal as victims could sue the companies that produced bad medicines for millions. Bad drugs would still be banned on a reactionary basis, rather than preemptively banning all drugs and only approving the ones that can meet a ridiculous threshold. Doctors are not idiots and would do their best to make sure their patients aren't getting snake oil.
I'm not saying this is a perfect system, I'm saying the FDA is so bad it manages to be worse than this.
Get your story straight.
If you can't understand the problems with vetting a device to be used by quite a few people, then you're just being foolish.
Given how short a news cycle is becoming, perhaps this is not such a great thing to ask for anymore.
I like watching "Angry Joe's" reviews for video games, which I note can come out up to a month after the official release date. You may find his review style offputting and I don't always agree with his conclusions, but it's obvious that he actually puts the time in, whereas other journalists are, at times, clearly reviewing games on the basis of playing through the first couple of levels yesterday. I'd like to see this in more media.
That said, it would be absolutely stunning to peek under the covers of major journalism outfits and understand exactly how the sausage gets made and how the flows of power route. Why does X get covered, Y doesn't? How much do journalists take direction, in practice, from outside sources, and how much investigative journalism do they really do? I don't know.
Reminds me of when I read stories saying that a government official briefed reporters in the condition that the official not be named. The press in that situation willingly let itself become the government's propaganda arm. Journalists need to look in the mirror here too.
This is a long-discussed issue with video games. If you say "no reviews for our video game until release", that's just controlling timing. If you say "no negative reviews for our video game until release", you're manipulating the narrative. You don't ask anyone to lie (good reviews can still be totally sincere), but the gestalt is no longer natural.
> "Embargoes that attempt to control sourcing are dangerous"
It appears that the FDA is using conditional embargoes, and their specific conditions are what shocked reporters.
What I'm seeing fairly often is "Review embargo: nth Month; Streaming embargo: n-7th Month". While there's an argument for it (reviewing a game takes time, but a stream can be done cold), I suspect it (in some cases at least) is a way to make sure good coverage comes out first - a streamer probably isn't going to be digging completely into the flaws of a game, and they are actively playing to an audience/trying to be entertaining, potentially making a mediocre game look better. It's not quite the same as controlling review content, but it definitely feels manipulative.
If I was an editor, that deal would have been a much more interesting story than whatever they were explicitly trying to report.
They cannot be trusted.
http://slatestarcodex.com/2016/09/13/some-context-for-that-n...
Or should we just give up and decide for ourselves, for example, that vaccines cause autism, or that the government shouldn't even try to prevent poisonous foods from being sold?
Even a close-hold embargo wouldn't constrain a reporter without the reporter's consent;
the reporter can simply wait until the embargo expires and speak to outside sources,
albeit at the cost of filing the story a little bit later.
Alas, Kiernan says, there isn't any movement within the journalism community to change things.In this case, the FDA was releasing new rules that would affect medical device manufacturers and hence their stock prices. If reporters went around asking industry people for comment about this, then they would have been spreading material non-public information that would very likely affect stock prices in those manufacturers.
The embargo doesn't ban reporters from interviewing outside sources altogether. It only bans them from doing so until a certain time. If the journalist wants to be responsible, they can start interviewing after that time, and then publish a well-researched paper.
Lots of assumptions are being made about intentions, but perhaps this article makes the issue seem more evil/conspiracy-like than it is.
Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.
This is yet more evidence that this administration is one of the worst ever in terms undermining the ability of the press to provide accountability and transparency.
This is a major problem with science coverage. Media is forced to run what is effectively a press release. Stories that are then retracted (the story of easily-generating pluripotent stem cells a few years ago didn't pass my limited smell test and were then revealed to be faked) cause the public to be rightfully distrustful of science coverage and science.
Not to mention the handling of regulatory bodies; has anyone seen any coverage of e-cigarettes after the FDA's regulations change that didn't have sentences to the effect of, "E-cigarettes are promoted as safer than cigarettes. But this shows the aren't completely safe."?
Embargoes are a communications and marketing tool. Whether public institutions should value story telling over letting the facts stand for themselves is really the question. The culture today puts a lot value on stories...
You basically get one chance in your career as a journalist to really do the right thing, and then after that you can't do your day-to-day job.
FDA's existence seem to put a significant cost on doctors, pharma companies, patients and everyone related with no apparent benefit. Surely we can point one or two occasions where FDA might have saved American health but have we measured the times it actually harmed Americans by peddling falsehoods, increasing cost of drugs and delaying innovation ?
Plenty of research seem to exist to point out that FDA might be doing more harm to us than good. http://www.fdareview.org/05_harm.php
It has a very similar process for drug approval, including a mindblowing shit-pile of regulations for what constitutes approval, what can and cannot be sold, and what the government will pay for.
On, and the best part? It piggybacks off FDA approval, via mutual exchange of information between the parties. If you got FDA approval for your drug, you will have a much easier time selling it in Canada.
Don't tear down a fence, unless you understand why it was built. Medicine is a shit-pile of complicated, and there's no shortage of people willing to peddle snake oil - or, starting from the best intentions, grossly misunderstand the efficacy of a treatment. There are always compromises that have to be made, between ensuring timely, affordable access to drugs, and being sure that those drugs actually behave as advertised.
Some of the tradeoffs currently made may not be optimal - however, to dismiss them out of hand, without thoroughly understanding them is hubris.
This door spins almost as fast as the one between the Big Banks and the SEC.
The current commissioner of the FDA used to be a paid consultant for the the Pharma industry and that was the reason they backdoored him into the spot [1] (after getting him in as some other position)
[1] http://www.nytimes.com/2015/09/20/health/fda-nominee-califfs...