F.D.A. Surveillance of Scientists Spread to Outside Critics | Hacker News Reader

F.D.A. Surveillance of Scientists Spread to Outside Critics

nytimes.com

88 pointsjamesbritt25 comments

Did the NYTimes article change its title? The HN article reads "F.D.A. Surveillance of Scientists Spread to Outside Critics", but the NYTimes article's title is "F.D.A. Spied on Its Scientists' E-Mails in Bid to Cut Criticism".

The new title seems more accurate. It's still no good at all (obviously), but it doesn't appear that they monitored any computers except their own employees' computers. Of course, that ends up intercepting both sides of any conversation, which may often include non-employees; but that's generally the case when any employer monitors their employees' email (as many do). The questionable part would be whether this violated whistleblower protections, i.e. it was done in retaliation for a complaint.

(I'm more generally wary of employers reading their employees' email, but afaict it's widespread and legal, if not done in some kind of prohibited retaliatory manner. At least, that's the case in the U.S.; I believe some other countries may have privacy laws that restrict what employers can read.)

They might be running some automated A/B testing to find the most effective headline. Currently the headline is for me "Vast Effort by F.D.A. Spied on E-Mails of Its Own Scientists", while the page title is still the "F.D.A. Surveillance of Scientists Spread to Outside Critics".

Curious. Disappointing if they really are doing A/B testing! Those headlines all have significantly different connotations, so it would seriously lower my opinion of the NYTimes' journalism if they're choosing them based on linkbait potential, and not taking into account accuracy.

They might be doing A/B testing and SEO optimization as described for HuffPo here:

http://www.mondaynote.com/2012/07/08/transfer-of-value/

Headlines were bait before there were hyperlinks. Nothing new there—you're just seeing the process for the first time. Also, this doesn't take away from the substance of a very well-reported article.

Storing attorney-client communication seems pretty illegal to me.

Seems questionable to me also, but my understanding was that it's legal (and common) for employers to routinely read communications that take place on company-owned equipment. Do they have to stop reading it if they realize that the employee is communicating with an attorney? Or is it up to the employee to avoid using employer equipment for such purposes?

edit: Some searching digs up that the ABA model code of conduct suggests to attorneys that, as part of their duty of confidentiality, they should warn clients not to email them from their employer's email address. So it seems that the ABA is at least wary of whether such email would be confidential.

This is more complicated because their employer is an agency of the United States federal government.

True, that does complicate it a bit. I'm not an expert in this area by any stretch, but from what I've read, employees' rights are still pretty strongly curtailed. The courts have generally held that the government acting in its role as employer, rather than its police-power role, has roughly the same authority as a private employer would have with respect to its employees. The test for which role it's acting in at a given time is basically whether the search could reasonably be considered work-related. http://en.wikipedia.org/wiki/Ontario_v._Quon was a recent case.

Read the source HTML on New York Times articles, and scan the New York Times front page online from time to time to see the variety of ways that headlines can appear on the same article from the New York Times. I sometimes see a headline first as link text that leads me to the article, and then see a different headline as the article itself displays in my browswer. If I like the article and then think about submitting it here on HN, I have to think about which submission headline will be give readers an idea of what the article is about and what aspect of a hacker's intellectual curiosity the article might gratify.

To sum up, there is not always a one-to-one correspondence between articles and headlines as the New York Times is hosted on the Web.

It's common for what appears as the NYT article title to differ from what appears in the title element.

I use a bookmarklet to submit articles and it automagically grabs the title element content. I leave it as-is if it's close enough.

I'm hoping, with the expectation of ultimate disappointment, that someone will soon reign in this Do What The Frak We Want Because We Can attitude of officials within the U.S. government. At the least it's despicable. I'd venture a guess to say this behavior by the FDA management is illegal. However, I'm sure they'll prove to be untouchable.

However, I'm sure they'll prove to be untouchable.

That remains to be seen. The New York Times reporting points out that the FDA administrators spied on correspondence with members of Congress of both parties, who are appalled that that spying happens. That's a dangerous mistake to make in an agency funded by appropriations from Congress.

How many drugs and/or medical devices that are on the market do you think are going to lose their FDA-approved status? Probably zero. At most the one or two that are mentioned in this article. But the chances of having a systematic review conducted on all of the approved drugs to look for wrongdoing is basically zero, despite the fact that the ethics problems and corruption within the FDA are systematic.

How many drugs and/or medical devices that are on the market do you think are going to lose their FDA-approved status? Probably zero.

Counterexamples to your expression of personal belief are the drugs and medical devices that have already been withdrawn from the market for all indications or for some previous indications by the FDA. The list below is far from exhaustive.

http://en.wikipedia.org/wiki/Temafloxacin

http://en.wikipedia.org/wiki/Fen-phen

http://en.wikipedia.org/wiki/Terfenadine

http://en.wikipedia.org/wiki/Troglitazone

http://en.wikipedia.org/wiki/Tegaserod

(See also page 45 of an FDA report.)

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/Wh...

Other drugs have been withdrawn voluntarily from the market by the companies that make them when problems have appeared in their use.

http://en.wikipedia.org/wiki/Cerivastatin

http://en.wikipedia.org/wiki/Rofecoxib

Other drugs approved in other countries never received FDA approval in the first place.

http://en.wikipedia.org/wiki/Tolrestat

http://en.wikipedia.org/wiki/Ximelagatran

http://en.wikipedia.org/wiki/Rimonabant

The FDA continues to review other drugs with a view toward withdrawing approval from some of them.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc...

The FDA also nudges companies to withdraw drugs on their own part.

http://www.fda.gov/Drugs/DrugSafety/ucm277114.htm

Further, the FDA recalls drugs and medical devices if particular manufacturing batches are shown to have defects.

http://www.fda.gov/safety/recalls/default.htm

The simple fact of the matter is that the FDA, like any regulatory agency in a democratic country with a free press, gets pushed from all sides. Sometimes criticism of the FDA takes the form that it is too slow to approve drugs or medical devices that are already approved in other countries. Simultaneously there is criticism that the FDA approves some drugs or medical devices without full information from the companies that make them.

I have lived in another developed country with a national health insurance system (for which I was eligible as a foreign resident with a visa that included work permission) and highly educated physicians and some central government regulation of drugs and medical devices. Sure enough, there were drugs there available by prescription that are not available in the United States, and the other way around. Each country's political system balances risk and benefits in its regulatory framework, subject to political pressures of various kinds and trumped in the end by the clinical facts of who lives or dies while taking various drugs or using various medical devices. My son the hacker spent last summer working for one of the large medical device companies in my town, and EVERYTHING about his work was stringently reviewed by the FDA, so much so that the work he completed will probably not see the market for a few more years yet.

Alex, I see you are part of that minority of HN users who joined much earlier than I did (which is what I recalled before I checked your user profile). I appreciate many of your posts. I don't know if anyone else here has told you this, but just as you see that I post in a lot of threads about medical research or medical practice regulation (because my mother was a nurse in a research hospital, and indeed was one of the first persons in the entire world to learn how to assemble and disassemble a heart-lung machine), I see that you post a lot on those issues. You appear to come to HN with a worldview that regulation of prescribed drugs has mostly failed, and medical practice in general is ineffective. And yet you also seem to have a view about controlled subtances that is not fully consistent with that point of view, because street drugs that have had no rigorous studies of safety and effectiveness (and are known to put people into hospital emergency rooms from time to time with deadly symptoms) are sometimes championed by you in other posts, while prescription drugs that have been carefully studied in that regarded are doubted in most of your posts.

I would suggest to anyone reading this that it would be more consistent to subject ALL of your beliefs to the test of evidence and to find out if ANY drug, prescribed or illicit, really provides benefit to the user, and if ANY seller of drugs, "Big Pharma" or your favorite local dealer, has any other motive in mind besides making money. The commonplace HN meme of "drugs approved by the FDA are bad," while "drugs prohibited by the DEA are good" is unlikely to be true in general on its face, and anyway has to be tested with good evidence on a case-by-case basis.

I appreciate your perspective. To address some of your points:

1) "The simple fact of the matter is that the FDA, like any regulatory agency in a democratic country with a free press, gets pushed from all sides. Sometimes criticism of the FDA takes the form that it is too slow to approve drugs or medical devices that are already approved in other countries. Simultaneously there is criticism that the FDA approves some drugs or medical devices without full information from the companies that make them."

I think these are good points, and I'm aware that drugs lose their FDA approval or get pulled off the market from time to time. This is generally good. My issue is that a lot of drugs that get approved do so on really shoddy science. I've documented this extensively in previous posts, but some of the highlights:

- To get approved, you generally only need to show that a drug is safe and effective for one indication for six weeks or so. There generally isn't any requirement to show that drugs are safe or effective for longterm use, even if they are generally marketed and prescribed for longterm use. A good example of this is with various psychiatric drugs, as Robert Whitaker documents in his book Anatomy of an Epidemic.

- There have been many, many cases of pharma companies faking their research data, hiding bad results, bribing doctors to prescribe certain drugs, etc. And the most these pharma companies ever get is a slap on the wrist, usually a fine much less than the profits they have made over the years.

- There is currently to mechanism is place to get FDA approval for non patentable drugs. The number of non patentable drugs that make it into the marketplace is effectively zero, even though there are many non patentable drugs that are potentially more safe and effective than drugs that can be patented.

- Many of the new drugs approved are simply evergreened versions of existing drugs, designed solely to extend the patents of pharma companies. I wouldn't have a problem with this if these drugs were genuinely better, but usually they aren't. The FDA generally goes out of its way to allow drug companies to market their evergreens as being more effective or having less side effects, even if there isn't nearly enough research (or no research at all) to believe that these things are though.

- Many of the epistemological assumptions behind the current paradigms of pharmacology are highly dubious. (Again, I have made my case for this many times elsewhere so it would be largely a waste of everyones time for me to go into this again here.)

My attitude toward the FDA isn't that it should be abolished. I firmly believe that government regulation is needed, I just think the FDA is doing a really bad job currently.

2) "...medical practice in general is ineffective."

I generally try to be careful not to make statements to that effect, even though I am critical of the medical system in the vast majority of my posts. Basically in order to say that you would need to know:

- What percent of the time are doctors able to make a diagnosis? What percentage of the time are patients diagnosed correctly?

- What percent of the time do they get the appropriate treatment for their condition?

- What percent of the time are patients better off as a result of going through the medical system?

If you have better research I'd love to see it, but the best and most current information on this I've been able to find is as follows:

"Perhaps the most striking revelation to emerge from this review is the surprisingly small amount of systematic knowledge available on the quality of health care delivered in the United States. Even though health care is a huge industry that affects the lives of most Americans, we have only snapshots of information about particular conditions, types of surgery, and locations of care.

The dominant finding of our review is that there are large gaps between the care people should receive and the care they do receive. This is true for all three types of care—preventive, acute, and chronic—whether one goes for a check-up, a sore throat, or diabetic care. It is true whether one looks at overuse or underuse. It is true in different types of health care facilities and for different types of health insurance. It is true for all age groups, from children to the elderly. And it is true whether one is looking at the whole country or a single city."

[...]

"A simple average of the findings of the preventive care studies shows that about 50 percent of people received recommended care. (None of the studies reported a percentage of people receiving contraindicated preventive care.) An average of 70 percent of patients received recom- mended acute care, and 30 percent received contraindicated acute care. For chronic conditions, 60 percent received recommended care and 20 percent received contraindicated care. These values do not indicate exact levels of quality in the United States, but they do provide a quantitative sense of how much could be done in all areas to identify and eliminate overuse and underuse of care. [...]

The United States cannot afford to let this situation continue. A systematic strategy for routine monitoring and reporting on quality, as well as the information systems needed to support such activities, will be essential if we are to preserve the best of the American health care system while striving to improve the efficiency with which high-quality services are provided." Source: http://www.innovationlabs.com/summit/summit3/readings/Schust... (How good is the quality of health care in the United States?)

I have a lot more research notes on various things related to the healthcare system and the state of health in the US, two very different but related things, and I'm going to publish those notes at some point as sort of a citation vault. (I'll send you note now though with some stuff for you to peruse.)

3) "because street drugs that have had no rigorous studies of safety and effectiveness (and are known to put people into hospital emergency rooms from time to time with deadly symptoms) are sometimes championed by you in other posts, while prescription drugs that have been carefully studied in that regarded are doubted in most of your posts."

I think this is a mistaken belief on your behalf. Almost all of the commonly used street drugs have more research on them than all but the most well studied prescription drugs. And all of the most studied drugs in general are the so-called recreational drugs. For example there are over 20,000 studies on marijuana and cannabinoids alone. Similarly, you'd be hard pressed to find any antidepressant with more research done on it than LSD and Psilocybin. There are many books that sum up the scientific research about specific drugs. For example, the book Marijuana Myths, Marijuana Facts has a good summary of marijuana, although it's about ten years out of date. The book Marijuana Is Safer also has a good summary of the research, although it doesn't cover every single point. There is a good podcast with an RN about some specific medical benefits that I often link to, which you can see here: http://www.matrixmasters.net/salon/?p=258

I actually have some Squidoo pages with extensive collections of research on marijuana and psychedelics, although HN does not let you link to Squidoo pages. (But you can probably find them via Google or through the internal site search engine, and then find the rest via my profile.)

I do occasionally advocate illegal drugs for certain specific issues, but more generally I'm an advocate of more sensible drug laws. I generally believe that virtually all drugs should be legal, the government should regulate the purity and quality, and there should be some sort of drivers license type system in order to get certified to use different clases of drugs. (E.g. there would be a certification for psychedelics, a certification for opiates, etc, as well as certification for different delivery methods.) And if you're not certified then you could still use various drugs under a doctors supervision, either on an inpatient or outpatient basis depending on the drug/dose/delivery method.

Also, as a general rule of thumb there aren't really any safe or unsafe drugs, just safe and unsafe use patterns. Unfortunately I think the government is larger pushing people away from safer drugs / usage patterns and toward more dangerous practices. The book Marijuana Is Safer makes a good case for this for marijuana, but really marijuana is just one drug in a much larger argument.

Hopefully this explains at least a little better about the bigger picture of what I believe and why.

The most frightening part here is that at the end of the day, criticisms of this kind have historically led to increases in FDA budgets, because the more the agency fails, the more people cry that it is underfunded in its crucial mission to protect public health. See for example the "Alliance for a Stronger FDA", in which many drug companies lobby for increased FDA funding, both to curry favor with current officials and to exclude competitors.

http://strengthenfda.org/

http://cherryhill.legalexaminer.com/fda-and-prescription-dru...

http://www.washingtonpost.com/business/economy/fda-funding-b...

As these links show, more failure means more funding, but sometimes also shakeup which reduces the upward arc of a bureaucrat's career and limits them to "just" lifetime employment with tenure (it's called 'career status' and federal employees get it after three years).

So, if this is how they react to cries that the agency is underfunded, can you imagine how the FDA would react to criticism that might result in decreased funding?

More failure means more funding... could apply to almost any government bureaucracy. Department of Education comes to mind.

They don't need more funding. They need fewer managers and administrators and more technical subject experts.

It seems to me somewhat naive to expect in these conflict scenarios no recording/spying on devices that are owned by the employer.

But I am wondering based on this case: How does "corporate" America regulate the use of private communication devices in general? Are employees who work on non-secretive areas generally allowed to bring personal communication devices into the office (how about a smartphone? a tablet? or a netbook?).

or bring kit, leave it in the bag/car pop out to a wifi connected cafe at lunchtime or in the evening after work? I was wondering that as well.

UK: Regulation of Investigative Powers Act and European Privacy Directive might need to be read carefully but I'm pretty sure e-mails of this nature would be private.

Example of Spector360 use in Australia:

http://www.smh.com.au/technology/technology-news/public-serv...

If the FDA has "confidential agency information", they are doing it wrong.

I'm not sure I fully agree with that. Drug companies should be able to take as long as is needed to make sure a drug is safe without having to tip their hand early to competitors.

How does that work with the idea that patents are only for limited times?

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