
F.D.A. Surveillance of Scientists Spread to Outside Critics - jamesbritt
https://www.nytimes.com/2012/07/15/us/fda-surveillance-of-scientists-spread-to-outside-critics.html?_r=1&pagewanted=all
======
_delirium
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.)

~~~
stfu
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".

~~~
_delirium
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.

~~~
wib
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.

------
delinka
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.

~~~
tokenadult
_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.

~~~
Alex3917
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.

~~~
tokenadult
_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...](http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/WhatWeDo/UCM078935.pdf)

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...](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm)

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.

~~~
Alex3917
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&mdash;preventive, acute, and chronic&mdash;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...](http://www.innovationlabs.com/summit/summit3/readings/Schuster-
McGlynn-Brook_How%20Good%20is%20the%20Quality%20of%20HC_Millbank_2005.pdf)
(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.

------
temphn
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://cherryhill.legalexaminer.com/fda-and-prescription-drugs/fda-is-
understaffed-underfunded-and-cant-handle-food-
inspections.aspx?googleid=255906)

[http://www.washingtonpost.com/business/economy/fda-
funding-b...](http://www.washingtonpost.com/business/economy/fda-funding-
boosted-through-lobbying-effort/2011/11/23/gIQAXHQ6CO_story.html)

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?

~~~
ams6110
More failure means more funding... could apply to almost any government
bureaucracy. Department of Education comes to mind.

------
stfu
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?).

~~~
keithpeter
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.

------
kaarlo_n
Example of Spector360 use in Australia:

[http://www.smh.com.au/technology/technology-news/public-
serv...](http://www.smh.com.au/technology/technology-news/public-servant-
sacked-for-googling-knockers-at-home-20110202-1adue.html)

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

~~~
eli
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.

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

