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Counterexamples to your expression of personal belief are the drugs and medical devices that have already been withdrawn from the market for all indications or for some previous indications by the FDA.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.
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 joine...
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&#...
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.
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.
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.
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 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.
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.
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?
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.
26 comments
[ 2.9 ms ] story [ 69.7 ms ] threadThat 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.
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 joine...
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&#...
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.)
http://www.mondaynote.com/2012/07/08/transfer-of-value/
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.
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.
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.
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?).
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.
http://www.smh.com.au/technology/technology-news/public-serv...
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?