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.
See, I do feel for the FDA. Trying to message things properly is like trying to send a smoke signal in a hurricane.
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.
This is apologism. I expect an expensive organization, that I pay for, to make their the case to the public without dirty tricks and intimidation. And I expect the news sources that I am intelligent enough to pick to investigate and report with integrity. I see plenty of fair, loud, and clear venues the FDA could have used.
Again, I don't think he's assuming anything. I read his comment as using "expect" to mean "they really really realy should, and it's a problem if they're not".
Indeed. One can expect all one wants, but the business incentives for the media are strongly opposing integrity and truth. Which one can see daily, most obviously when some outlet is reporting on a topic one has direct experience with.
Hmm... I intended this to be understanding of the situation, but scathing in tone - as in, "FDA, at least to us, this makes it look like you are engaging in 'Diabolical Action Z,' and we don't really have a good way to discern differently without investing dozens of hours of effort, and even then it's uncertain, given our collective expertise level."
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."
Do you expect an expensive organization, that you pay for (Pharma company that makes your medicine) to also make their case to the public without dirty tricks and intimidation?
Private enterprise vs taxpayer funded government agency. Vastly different. A pharma company answers to shareholders, a government agency answers to taxpayers -- except they don't. Pharma companies don't owe you anything because you're a customer. You chose that relationship. However, we don't get to chose the FDA .. it's foisted upon us.
Preferential reporters by government agencies ought to be illegal.
You still pay for it, and thanks to patent protection, you need to pay that particular company for it if you don't want to be dead.
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.
Observing that there has been a steady trend of right-leaning opinions being blasted across every thread is not a "conspiracy-theory" (it's extremely ironic that you chose to label it in such a way, in a thread with some heavy conspiratorial overtones about the FDA) when mediums such as hackernews often have a tendency to drift that way as they become more popular. If there is even a hint of a progressive idea in any statement you make on here these days, it gets immediately down voted.
There was no reason to downvote me, so you can concentrate on the source of the problem instead of throwing a silly rule at me. But it's far easier to just pinpoint a silly edit I made, isn't it? Let's completely ignore the fact that we are on a thread about the government controlling the media and that it was somehow sufficiently voted up to receive significant attention and that my initial statement somehow warranted downvotes.
The FDA is not stopping the press, they are preventing them from misreporting their statements and processes. Spare me the over-zealous "independent" label. The press isn't some magical segment of society with high standards and accountability.
And these general sentiments are definitely "alt-right." It has a generally conspiratorial tone with completely overzealous fear mongering about what the FDA is doing.
I don't think I will spare you the "independent" label, thanks.
The press is a deeply flawed institution. The idea that what the press needs to become less flawed is to be more controlled by the subjects of their reporting is, frankly, idiotic. It's genuinely the stupidest thing I've heard this week.
I have no particular bone to pick with the FDA. I neither revere nor hate it. I don't want to defund it, but neither do I think it is above all reproach, nor that it is above trying to make itself look better than it is. But this isn't really about the FDA in particular, but about the general relationship of the subjects of reporting with the press in general, and particularly about the relationship of the government with the press.
Having as reliable as possible information about what our own government is doing is a bedrock foundation of a functioning democracy. We should be doing what we can to make sure that we get that information, not celebrating the government's attempts to manipulate the press. The certainly does not preclude criticizing the press for their many failures, but it does mean supporting them when they do the right thing, as the Scientific American is here.
PS: As far as the general sentiments of the alt-right go, the alt-right is defined by a belief that we should have a more authoritarian government that maintains order and ignores democracy. Guess who sounds kind of alt-right-ish in this conversation?
No one is controlling the press. I am not sure where you are hearing that, but it's genuinely concerning that you seem to be concerned about things that aren't happening.
The government is not blocking any information. It is managing contacts. It wants trust worthy contacts who aren't going to spin things around for financial gain.
The actual information related to their policies are accessible again, by people who actually understand the material. Thousands and thousands of scientists from competing organizations observe and consume information from the FDA. There is nothing stopping journalists from seeking out this information and gathering opinions from the employees of these organizations, or professionals in whatever field they're reporting on in general.
"Do the right thing." How shallow and means absolutely nothing in the context of this conversation. Please say something a bit more substantial than that. The FDA wants to interact with reporters who don't spin information or misquote members of the FDA for their own gain. That's literally it. What's this "do the right thing" battle cry in reference to again?
It's extremely aggravating that this needs to spelled out on this forum these days.
PS: Nothing about what the FDA doing is remotely authoritarian. Stop promoting click bait, and furthermore at the very least don't try pathetically defending it.
What? Nobody said "defund the FDA." My grandparent poster said he expected them not to use dirty tricks and intimidation, and my parent poster said that it was cool to control the press to "maintain order" (<-- seriously, that's a quote!) and intimated that not controlling the press to maintain order was an alt-right position.
A belief in an independent, skeptical, and indeed antagonistic press was a core left-wing value as of, like, the late 20th Century. I think it still is or ought to be.
The FDA is not stopping journalists from being "independent, skeptical." It is stopping journalists who attend their press releases from misquoting their statements -- which in case you missed out on a little bit of history has definitely happened with the FDA in the past.
That could be seen as false equivocation of positions. The FDA is an organization that needs to broadcast signals to nearly every level of society about certain products. All the way from corporate RnD divisions to consumers.
Not being concise, diligent, and stringent on what messages get sent out could have extremely negative effects. Letting news organizations pander to people's fears or general ignorance is a recipe for disaster.
I am not even sure why this needs to be explained. I mean, actually at this point on HN I do know why, it's people being disingenuous. Seriously how is this non-sense being upvoted?
From the article:
>including ones from major outlets such as Fox News
Seriously, are we going to just sit here and pretend why this was done? An organization hell bent on bashing largely agreed upon scientific information is being denied the ability to spin information from an organization dedicated to the scientific understanding and safety of products. The FDA is basically refusing to play the game of yellow journalism and rightly so.
Spare me the patronizing pathetic attempts at an apology, and excuse me for calling out bullshit from scientific american. Shame on them. And shame on HN for upvoting this.
So you are saying that the FDA is never wrong and that its activities need no public oversight? I can see no other reason for allowing them uncontested access to spin their "signals".
If they were interested in "refusing to play the game of yellow journalism" they would not pre-announce their activities at all.
And are you really saying that Scientific American is "an organization hell bent on bashing largely agreed upon scientific information"?
No where did I say the FDA "is never wrong and that its activities need no public oversight." No part of my statement could even be misconstrued that way. But thanks for being disingenuous!
The FDA gets _true_ oversight from the thousands and thousands of scientist who work within the organization, who work outside the organization, and other organizations who have vested interests in "trashing" certain findings and approvals by the FDA. It sounds like you don't know how the FDA is generally set up so it would do you well to look into it. It's not exactly private.
The FDA again, doesn't want to play the game of yellow journalism. Why is this confusing? The following makes absolutely no sense, by the way. From your own post: "they would not pre-announce their activities at all." Please do elaborate how this somehow negates their motivations for not wanting the press to get out of hand and send false signals to the public. You can't just provide one little quip and expect that to unravel all their motivations. Again, I'm really struggling to see how this is confusing to anyone who has worked with anything remotely public, or even at a big corporation!
And no, I am not sure how a direct quote about Fox News and a sentence that follows the direct quote somehow gets misconstrued as me talking about "Scientific American." _However_, Scientific American has been known (especially over the last couple of years), to engage in generally click baity, irrefutably unscientific publications. Just like it is doing here.
You don't know what Yellow Journalism is. Actually, the FDA is PROMOTING yellow journalism because they refuse to allow reporters to interview independent sources prior to the embargo being lifted. So they are willingly supporting a policy that makes journalist less likely to seek corroborating or conflicting sources thus leading to inaccurate and even sensationalized reporting.
Your hatred of Fox News is noted, however the government has no right to discriminate against media outlets. Considering that Fox has the largest viewership of any US news channel, you'd think that the FDA would have a mandate to ensure that their policies were reported to the largest audience.
Seriously, Politico was on the preferential list and not Fox? That's just pettiness on the part of the FDA and it's obvious that they have an agenda. My point isn't that Fox isn't given advance access -- my point is that there ought not be exclusionary access lists in the first place.
>Actually, the FDA is PROMOTING yellow journalism because they refuse to allow reporters to interview independent sources prior to the embargo being lifted.
That is the most backwards statement you possible could have made. I am not even sure if you really believe it yourself.
>however the government has no right to discriminate against media outlets.
Yes they do.
>my point is that there ought not be exclusionary access lists in the first place.
And you've done nothing to negate my point that not only that they should and it makes sense to do so, but why you think letting news organizations run wild with public health information is a responsible thing to do. It's foolish, naive, and ignorant.
I can understand the argument that stonewalling outright hostile news organizations like Fox News is justified. I don't know whether I agree with it, but I can understand it.
But that is essentially orthogonal to the issue of whether embargoes should be "close-hold", in those cases where the FDA does trust a reporter enough to grant them early access. After all, if the reporter merely wants to cast aspersions and FUD, a close-hold embargo doesn't really prevent them from doing so; they can probably come up with it on their own, or cite preexisting criticism related to the subject (regardless of how well it matches up with the exact announcement at hand). It is only if they want to get informed, on-topic reactions from sources with relevant knowledge and experience that the embargo gets in the way. Indeed, such an embargo may all but force even well-meaning journalists to include misleading or useless "context" - decreasing the accuracy of the article - just to provide some slight semblance of impartiality, as in this example from the Scientific American article:
> CBS plunked down an out-of-context quotation from the director of the Centers for Disease Control and Prevention, probably in hopes that readers wouldn't notice that it was two months old.
Now, I suppose it's possible that well-meaning journalists end up too credulously repeating the statements of sources with, as you say, vested interests in bashing the FDA. I suppose hamstringing them from even talking to those sources, along with all others, could hypothetically increase the overall accuracy of the article.
But let's be real. What you end up with is essentially a series of glorified press releases. Press releases have their place: to inform the public of a particular organization's viewpoint. True, the FDA is an expert organization and chances are its viewpoints are typically reasonable - valid - plausible. Indeed, they're almost certainly more studied and thorough than a quick reaction from any other source. But even so, valid is not the same as right, and for issues as contentious as the ones the FDA often ends up having to deal with, there is rarely any single right viewpoint. Thus citing a range of sources, rather than providing the public with any organization's viewpoint alone, is the only responsible thing to do. That is not yellow journalism: it is the essence of journalism.
Seriously: do you really think -
> Even after he updated his piece later in the day to get some outside comments, there was little hint of how controversial the new rules were. Members of the tobacco industry were generally unhappy with increased federal regulation of their business, while antitobacco advocates tended to argue that the new regulations were far too weak and took way too long to promulgate. And there was no mention, in Felberbaum's article, at least, that the agency had tried to regulate e-cigarettes several years earlier but was slapped down with a stinging rebuke from the U.S. District Court for the District of Columbia
> a close-hold embargo doesn't really prevent them from doing so;
It makes it pretty difficult to have any kind of information to spin. Whether or not it's 100% preventative measure is as you say, orthogonal to helping prevent the issue in the first place. If they have nothing to quote of context, or twist their words, any material they make will be generally lackluster to their audiences.
>What you end up with is essentially a series of glorified press releases.
The FDA does not have a PR branch. It is smartly using the press to get information out to the public.
>But even so, valid is not the same as right, and for issues as contentious as the ones the FDA often ends up having to deal with, there is rarely any single right viewpoint.
Allow me to be extremely blunt here: who cares? Again these view points are largely handled through the actual scientific process. The general public with no knowledge on the subject being discussed isn't going to properly shift through competing view points, and it is exceedingly unlikely these other view points are correct by the time the FDA wants to give a press release about certain processes or products.
Again, this information about these other view points isn't private. The FDA just doesn't want the press to misinform the public. What is so controversial about this?
>Thus citing a range of sources, rather than providing the public with any organization's viewpoint alone, is the only responsible thing to do.
There is nothing stopping organizations from researching these issues on their own and reporting them. The FDA just doesn't want the press to spin their statements into something that could harm the public in any form. If you go to a press event, you are expected to report accurately on FDA's statements and processes, or else you're not going to be invited back.
I would like an explanation what the big deal is about actions the FDA are specifically taking in direct regards to the close-hold embargo without resorting to absurd claims that the FDA is somehow ruining journalistic integrity. Report the statements accurately and when the FDA is ready for the public to view them. Journalistic integrity is not being ruined. Journalists can still investigate the products on their own, and report other organization's findings.
>that omitting this context is an improvement?
The real question is how is that paragraph adding anything of value to the new rules and regulations by the FDA? People tend to get lost in the minuet talking points and stick to pedantic details with stories like these. Again, the FDA wants to have direct statements on these matters so there isn't any confusion about what they're doing or what they're going to try do.
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?
Don't over-think it: systemic failure as the result of institutionalized corruption.
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.)
What you're describing, to me, seems to be a symptom of information asymmetry/warping caused by a corrupt and ineffective corporate media.
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.
Hmm. Some descriptions work better as summaries of black-box behavior, than as insight into white-box causation and potential for intervention. I wonder if "corrupt and ineffective corporate media" is an instance of such.
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.
What are these "incredibly wealthy special interest groups"?
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.
Special interest groups are organisations that promote a specific interest. I would be shocked if drug companies didn't donate to groups that are critical of the FDA when it is in their interest.
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.
It may come as a surprise to some that the people running federal agencies often have their own best interests in mind most of the time -- rather than diligently serving the public.
The result is that the American media basically has become Pravda when it comes to the federal government.
> It may come as a surprise to some that the people <strike>running federal agencies</strike> often have their own best interests in mind most of the time
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.
Well the discussion was about the FDA. But I completely agree that people at all levels within government may use their privileged position for personal gain.
Meanwhile obesity (and related health complications) are skyrocketing despite a mounting body of evidence that shows saturated fat is not a causal factor...
Yeah, I submitted a story form the New Yorker by James Suroweicki (prob one of their best authors in my opinion) last week on the sugar industry getting caught red handed trying to push the fat = obesity narrative and it got zero traction:
"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."
This evidence will just be overturned in 15-30 years, when new studies show fat was really bad all along. Everything is healthy, if you wait long enough.
Are there good references for journalistic standards for embargos?
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?
The SPJ code of ethics[1] states that journalists should (because the "highest and primary obligation of ethical journalism is to serve the public"):
– 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.
.
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!)
.
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]
.
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]
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 other part: FDA is controlled by the companies that come under its umbrella. Think of the fox guarding the hen house.
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.
No no no, we people who come under its umbrella wish that it wasn't a FOX guarding the henhouse, but rather, a reliable dog. Instead, if we extend the metaphor, the fox that's guarding the henhouse is taking measure to make sure that the chickens are safe from everyone but him, and that fox is getting HUGELY STRONG from chicken dinner ever night, and walks back out into the forest and beats up all us other foxes. We'd love him to be locked out of the henhouse, or even, if necessary, for all us foxes to equally be able to access the henhouse, but instead we've got a massive, roid-raging fox terrorizing the forest, and it's freaking annoying.
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.
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...
First of all, see my comment above. The FDA costs way more lives than it saves.
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.
Agreed. Just take a look at some of the recent FDA decisions that absolutely slapped down the biggest pharma companies. I've worked in the industry for a while and I would say most big pharma tiptoes around the FDA since they can literally make or break you.
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.
Yes, and that proves the GP's point. The tobacco industry are the ones who'll remain largely unaffected by that ruling because they are grandfathered in from certification requirements. Oh, and also, they own a considerable size of the disposal e-cig market, so the relevant ruling effectively extinguishes the smaller players who sell re-usable kit.
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"
But finid still isn't wrong and you aren't either.
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.
Sorry, I don't depend on breaking news before I become familiar with something that affects me.
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.
This makes a pretty good argument for selecting news sources that aren't "first to print". If a news source is willing to be behind the curve, it indicates they're willing to report the news second hand and at least have the possibility of pursuing some due diligence.
I agree. It's tempting to jump to the natural conclusions about how bad all the people involved are, but this would lose a lot of its force if media gave up its game of shaving minutes or seconds off first publication and developed an ability to stick with a topic beyond one "news cycle", the very term of which implies the existence of the problem. It could be easier to fix the structural issues than the people issues.
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.
A few points. This is the aim, in part, of PR firms/departments: to shape and control the narrative, the public relationship. That a behind-the-scenes method is used to control the relationship should not be a surprise. That it is being embraced by the scientific authorities is surprising, frankly, and disappointing to me.
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.
It's fair to blame the FDA, but this article absolves journalists of any responsibility. No one is making them show up for these dog and pony shows.
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.
Are media embargos a new thing, or is just this reporter's first time around this block, and they're shocked to see the sausage get made. Quite frankly, the science press has failed to earn the trust of scientists day in and day out for as long as science press have taken that title.
The point I took is that conditional embargoes are much worse than simple ones.
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.
> You don't ask anyone to lie (good reviews can still be totally sincere), but the gestalt is no longer natural.
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.
Embargoes happen on the time; but usually controlling the narrative is super subtle rather than explicit. Most journalists aren't too critical of a source because they know next time they won't be given a release at all.
> The deal was this: NPR, along with a select group of media outlets, would get a briefing about an upcoming announcement by the U.S. Food and Drug Administration a day before anyone else. But in exchange for the scoop, NPR would have to abandon its reportorial independence. The FDA would dictate whom NPR's reporter could and couldn't interview.
If I was an editor, that deal would have been a much more interesting story than whatever they were explicitly trying to report.
Which company should we have listened to instead of the FDA?
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?
The last two paragraphs of the article says it all - the FDA has embargo power over the media, because the media can't cooperate to set their own embargo:
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.
That's funny because the article mentions plenty of journalistic oppositions of the the close-hold embargo from FOX News to Association of Health Care Journalists.
Why on earth would NPR accept that deal? I thought the whole point of public radio was that it was that by relying on donations it could maintain its independence and objectivity. There is no longer any reason for them to exist.
It's hard for me to understand that why NPR would give up their journalistic freedom to receive the briefing one day early. Is it that kind of a deal-breaker to report an FDA announcement a day later than some others?
In a perfect world, NPR would have done their article a day late, with the proper quotes from those affected, and would have explained in a footnote that this information would have been out a day earlier except that NPR could not ethically agree with the FDAs terms which were blah, blah, blah.
Then, for the next story, the FDA wouldn't even tell NPR about the possibility of the briefing, so NPR would start researching their story when other news organizations published their stories. The NPR would be release its story several days after the people who had the scoop, and fairly likely, its article would sink and vanish.
Is it just me that sees a legitimate need for close-hold embargoes in specific cases?
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.
Here, the US Government is clearly abridging the freedom of the press. It doesn't matter if it is 'consensual'. It is prohibited.
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.
"Also in 2014 the Harvard-Smithsonian Center for Astrophysics (CfA) used a close-hold embargo when it announced to a dozen reporters that researchers had discovered subtle signals of gravitational waves from the early universe. “You could only talk to other scientists who had seen the papers already; we didn't want them shared unduly,” says Christine Pulliam, the media relations manager for CfA. Unfortunately, the list of approved scientists provided by CfA listed only theoreticians, not experimentalists—and only an experimentalist was likely to see the flaw that doomed the study. (The team was seeing the signature of cosmic dust, not gravitational waves.) “I felt like a fool, in retrospect,” says Lemonick, who, as one of a dozen or so chosen journalists, covered the story for Time (at the time, he was not on the staff of Scientific American)."
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 an effective tool to ensure an certain minimum depth of reporting, control timing and prevent misunderstanding causing negative publications. They can be used to implement some limited idea of fairness and they can be used to exercise control.
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...
Someone -- I think here on HN -- described the catch 22 for journalists: They need access in order to do their jobs. But they will get denied access as soon as they use that access to tell a story that substantially upsets the people they cover.
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.
Is there any studies to indicate FDA is useful to Americans in any way? Despite the absolutely mindblowing sh*t-pile of regulations that this agency creates every year there does not seem to be any major difference between lifespans of Americans and neighboring Canada. Not to mention the EpiPen like fiascos are a direct result of FDA's collusion from very people it swears to protect us.
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 ?
Canada has an FDA equivalent, called Health Canada (The HPFB, to be precise.)
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.
One point I think in support of these types of embargoes is that news about an FDA announcement can have huge financial and business impacts and seeking responses would very likely leak that information to the businesses that will be impacted by announcement X.
"Manipulating the media" - what about the much more serious concern of the revolving door between Big Pharma and the FDA?
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)
One great idea is to just not give embargoes, just give everyone the same information at the same time. It seems like an embargo is a favor to the media companies, feeding this frenzy of "get out first" journalism. Instead, they should be all be "left in the cold" to quote the article.
While thinking about the FDa, please keep in mind how pervasivly Monsanto has inserted former employees into its ranks for their putposes (especially now in light of the Bayer buyout move). Sure big pharma et al have as well, but it's monsanto that pops up on my "6 degrees of kevin bacon" social graphs of them.
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.