[Link] Your genes, your rights – FDA’s Jeffrey Shuren not a fan

by [anonymous]1 min read9th Mar 201112 comments

6

Personal Blog

http://blogs.discovermagazine.com/gnxp/2011/03/your-genes-your-rights-fdas-jeffrey-shuren-not-a-fan/

 

I find myself basically agreeing with Razib.

Yes there is generally incompetence and avoidable irrationality associated with the most likley way this will be regulated. But I find myself fearing something else even more. I'm scared of busybody policy advisor's or "well meaning" individuals who will choose to hide or misrepresent data purposefully to either:

  • promote their own values
  • try and appease a popular "moral panic" (I think we will see at least one or two as uncomfortable new discoveries about the role of genetics are made or as old ones are made too blindingly obvious to ignore).

 

 

 

Thoughts?

12 comments, sorted by Highlighting new comments since Today at 8:57 PM
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I agree with Razib as well. The medical establishment is really a sham for those of us who read research papers on our own, and who don't need a middle man to interpret what's best for us (which often is not what is best for us). With the rapid pace of research, most medical textbooks get outdated very quickly. But these are still the same textbooks that doctors use to get their degrees.

And this is the first time I've ever seen Razib visibly angry (over 4 years of reading his blog), so it clearly means a lot.

By the way, does anyone have any more information about the Personal Genome Project? I got recruited as part of the 1k cohort back last October, but I still haven't heard anything back from them.

And does anyone know how I could get a MRI for as cheap as possible? (i tried doing clinical research, but they won't give me the results of the MRI)

You are overestimating the value of research and underestimating the value of experience/clinical teaching. There is a huge difference in medical understanding between a graduate of the 2nd year of medical school (when the textbook learning is mostly done) and an MD (6000 clinical hours). There is another huge leap in knowledge/judgment obtained in residency (another 10,000+ hours) - and after.

It obviously depends on what questions you are talking about - but be careful overestimating the value of research/textbooks in medical knowledge. There's a lot more than just that. Of course, none of this applies to genomics; that's not an area where doctors actually have much experience, and a well-read individual might well be better off in interpreting their own data. There are not really many doctors interested in restricting patient access to genomic data - this is the FDA at work. Different beast.

re: MRI's: where do you live?

[-][anonymous]10y 2

Comment on isteve by HH:

Steve here is a note I sent to the FDA a week or two ago.

"I am writing to comment on the meeting to be held March 8-9 about direct to consumer (DTC) genetic testing (Docket FDA-2011-N-0066). I am especially motivated to write after reading the plea to you by the AMA that any DTC results of possible medical interest be censored to consumers. Their letter reflects an appalling paternalistic arrogance that would violate basic freedoms and impede public scientific understanding. I presume that if they could they would have you ban bathroom scales on the grounds that body weight must only be revealed in consultation with a “qualified medical professional.”

The AMA submission has two main themes. The first is that citizens are unable to understand the risks and predicted outcomes that might be reported and that experts are vital to provide guidance. My own experience is that I am perfectly capable of finding empirical risks from current literature, I expect I can do a much better and more thorough job than my personal physician, and even my teenage son can do it with no trouble. My own experience, again, is that only about 1 in 5 medical students know what Bayes' Theorem is.

The second theme is that knowledge of potentially medically relevant genotypes can do some unspecified harm to customers. I have spent a total of six or so years on university IRBs, and this kind of worry is ever present. While there is much public loose talk about psychological harm and the like, within the committee room we all understand that the practice of withholding any data from subjects about themselves is nothing but protection from lawyers. I am perfectly free to refuse to participate in research and in clinical trials but I am not free to refuse to participate in federal censorship of knowledge of my own genotype.

I would urge you to keep freedom of information for consumers at the center of the table when you discuss regulation of the DTC genetic testing industry."

I'm surprised there isn't more activity about this here considering the strong presence of transhumanists.

My own experience, again, is that only about 1 in 5 medical students know what Bayes' Theorem is.

Just like how 1 in 5 medical students knows what the Hindu-Arabic number system is. So what? The whole problem is that medical students excel at rote memorization at the expense of genuine, model-based understanding.

What matters is whether med students can perform the kind of statistical inference codified by Bayes's Theorem -- whatever they call it -- not whether they can spit out the right password in response to the question, "What is Bayes's Theorem?" (and then go on to unjustifiably tell their patients they have breast cancer).

[-][anonymous]10y 1

Just like how 1 in 5 medical students knows what the Hindu-Arabic number system is.

Over here the Arabic and Roman numeral systems are compared and contrasted in primary school with a short word on both their development. This is done again with a bit more history in High School. I'm quite confident that if you said "Arabic numerals", 90%+ of Medical students would know what you are talking about. And in context 80%+ would infer or remember what the Hindu-Arabic numeral system is.

But me pointing out that your own password guessing example is country dependent or perhaps even false is utterly irrelevant because it makes a vivid example.

Its highly probable that Henry Harpending has a good handle on the difference between password guessing and knowledge it is reasonable to assume he meant that less than 1 in 5. can perform the kind of statistical inference codified by Bayes's theorem. Which I think you would agree with considering you, in my opinion accurately, stated that :

The whole problem is that medical students excel at rote memorization at the expense of genuine, model-based understanding.

Remember the sentence you are criticizing was a quote from a note he sent to the FDA not a quote from a rationalist discussion. Saying that:

that only about 1 in 5 medical students know what Bayes' Theorem is.

Is much more expedient than explaining what one really means. Short notes are more likley to get read. It also has the advantage of sounding bad to someone who has no inkling of what Bayes' Theorem or the knowledge that password is associated with is.

When one is sending a letter aimed at convincing someone of your point it is optimized only to convince.

So if I understand you correctly, HH's phrasing of his complaint about an irrelevant deficiency (whether the students know "Bayes's Theorem") is understandable because there's no similarly-expedient way to convey the same problem. I disagree. Watch:

"only about 1 in 5 medical students ...
... can perform Bayesian inference." [1]
... understand the impact of false positives in medical tests."
... reason consistently with Bayes's Theorem."
... can correctly estimate false positive rates."

I don't think those rephrasings require any kind of brilliance, just a willingness to convey what you actually mean, and looking for a way to do so.

When one is sending a letter aimed at convincing someone of your point it is optimized only to convince.

I hope not, because that's all the more reason for someone to ignore it! (If someone is willing to say anything to make a point, the listener should not expect a helpful relationship between the arguments and reality.) It should be optimized for persuasiveness under the constraint that one only say stuff that is actually relevant and true. No such constraint -> no reason to care what they have to say.

If it seems like I'm belaboring a minor point, it's because HH's phrasing implies that the important thing is for students to know this or that password -- the exact mentality we want to get rid of.

[1] Note: there is a huge difference between whether one can "perform" Bayesian inference -- which happened long before Bayes walked the earth -- and whether someone "knows what's Bayes's Theorem is".

[-][anonymous]10y 0

I hope not, because that's all the more reason for someone to ignore it! (If someone is willing to say anything to make a point, the listener should not expect a helpful relationship between the arguments and reality.) It should be optimized for persuasiveness under the constraint that one only say stuff that is actually relevant and true. No such constraint -> no reason to care what they have to say.

I think this goes without saying and all falls under optimizing to convince someone.

Its a queer scenario where you could get away with with not saying anything relevant and actually have this be optimal. But saying that the most persuasive argument possible is one where everything said is relevant and true is a bit hopelessly naive.

What really made your point is this:

So if I understand you correctly, HH's phrasing of his complaint about an irrelevant deficiency (whether the students know "Bayes's Theorem") is understandable because there's no similarly-expedient way to convey the same problem. I disagree.

And the examples you give.

In any case on second thought Harpending probably wasn't optimizing only for persuasiveness (though one might argue he should). I think he most likley was pretty cost efficient with regards to the amount of thought and effort he put into the note and its expected effect. So while I now concede your point I don't think this is particularly damning criticism. LW standards on this are, relatively speaking, pretty high.

I have a comment waiting in moderation on the isteve post Konkvistador mentioned, the gist of which is that the American ban on the use of genetic data by health insurers will cause increasing adverse selection as these services get better and cheaper, and that regulatory restrictions on consumer access to that data should be seen in that light. [Edit: it was actually on the follow-up.]

[-][anonymous]10y 0

"I think quite a few of us are with you on this Razib. My genetic code is mine to read and interpret or to give out to others to do the same. The power differential is already on the side of every relevant player except myself due to the messy reality of the scientific process (among other things its not that hard to misrepresent issues to forge “appropriate” expert opinion), taking away my right to choose who to trust or to read my code myself is a unacceptable step.

While I don’t live in the US, such madness seems ripe to spread among Western nations should it establish itself in a country as prestigious as the US, even secondary powers like France or Germany going that way sans the US would probably be bad news for all EU residents, since calls for a EU-wide policy would soon follow."

Comment I made there.

[-][anonymous]10y -1

At this rate, eventually someone will sue me for possessing genes that he's just patented. What a world we live in.