March 10, 2011

Harpending on personal genome freedom of information

Here is a comment posted on the earlier item about the Food and Drug Administration's crackdown on personal genome testing. It's from Henry Harpending, professor of anthropology at the U. of Utah:
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 witholding 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." 

25 comments:

Bill said...

Steve, you and Henry are totally missing what's really behind this.

It's a backdoor attempt to squeeze more money out of family law/child support issues.

Haven't you seen the endless Jerry Springer/Maury Povich "who's the daddy?" shows?

When being the "obligor" means hundreds of thousands of dollars in CS over the years, you can bet your bottom dollar that guys are going to pay up to be damn sure.

I have absolutely no doubt that the primary role of genetic testing will be to establish paternity in the near future. It probably already is. Do you think medical professionals are going to be so foolish as to pass up the kind of racket that's currently dominated by attorneys across the country to great and huge profit?

If any guy could send in a cheek swab of himself and his putative child to ascertain paternity in an open market, why, that's hundreds of millions of dollars per year that would otherwise be handled by "qualified medical professional[s]" who would be assured a steady stream of court-ordered tests.

Follow the money.

Anonymous said...

Well said.

Nanonymous said...

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

Lucky Henry Harpending. My experience is no more than 1 in 20.

Anonymous said...

great letter, but I am also annoyed I need a doctor's permission to get presciption drugs and any number of other medical tests.

Henry Harpending said...

@Bill:

Nice. Never occurred to me.

Henry

Big Bill said...

Inflatable cuff blood pressure machines are commonly sold over the counter in thousands of drug stores all over the USA.

We have all seen stacks of them on the shelves.

Yet in the early 1980s when I and others were developing these simple machines, they could only be used or obtained with a doctor's prescription.

It was not until large Japanese manufacturers ($$$) pressured the FDA that the government relinquished its chokehold.

We saw the same paternalism in against over-the-counter AIDS tests.

Follow the money.

Anonymous said...

And they wonder why medical care in this country is so expensive.

Anonymous said...

Constitutionally, I'm not sure such a restriction could stand. Disallowing knowledge of one's own genome without professional guidance is like refusing to allow someone to look in a mirror without a doctor's permission. Maybe the patient could be psychologically damaged by how ugly they are. The point is that these tests give knowledge about an integral part of oneself.

The proposed restriction is like not allowing women to self-administer and know the results of their own pregnancy tests. Might become a privacy issue.

Sword said...

Asuuming paterning tests is the thing:

What about men sending in DNA samples of themselves and their putative children to a non-USA genome testing agency?

I read somewhere that in Australia, it is forbidden to use non-court ordered gene tests for paternity findings, and if someone does get tests done outside Australia the results can not be used in court, and moreover he will be punished for the testing. To make matters worse, Doctors are - so that article said - under order to hide the truth, or even lie, if genetic testing done for other reasons (say, kidney transplant) shows that the putative father is not the biological father.

Chicago said...

They see their opportunity and are taking it. It's a growth industry so they have to move fast to sink their hooks into it before most people even become aware of it. The average citizen is just a mere child and can't know what's best for itself. Getting just raw data might, in some vague way, harm the tender psyche of the lowly citizenry. It's a money grab that uses contempt of the average citizen to fuel it.

Carl said...

But we don't need to know the fraction of doctors who understand Bayes theorem, we need to know the fraction of people who understand Bayes theorem that are doctors.

So the probability that someone who understands Bayes theorem is actually a doctor is equal to 20% of the fraction of people who are doctors, divided by the fraction of people who know Bayes theorem, right?

If only we knew how many people know Bayes theorem, then we could work out what fraction of them are or aren't doctors, and thus how sensible this legislation is.

jz said...

Dear Mr. Harpending,

You argue against paternalism.
The longer I practice medicine, I find paternalism is EXACTLY what patients want, although they don't feel free to state that.

The patients and families who seek out physicians do NOT want to input their own values, weigh the risks/benefits, and most importantly, they do NOT want to bear the consequences of their own decisions.

I'll accept your estimate that only 1/5 medical students understand Beyes' Theorem in an explicit fashion. Most physicians however, understand it in a practical functioning manner. How many patients understand Beyes' Theorem?

Anonymous said...

The administration apparently is uncomfortable with the notion that genetics is important at all.

They do well to fear.

As I wrote in several comments here in the last week or so - there is no education problem per se in America. There is a quite terrible problem with educating Blacks and Hispanics, but we can't speak of that. Bill Gates and Barack Obama recently met to discuss education issues. Did anyone mention different genetic capacities for benefiting from education?

There are about a dozen gene locuses that have been identified as connected somehow with intelligence. It's all very confusing right now but is sure to be better understood in the near future.

So the administration isn't so much afraid of an individual getting a report that says that he has a 3% greater than average risk of heart disease. They fear the report that says that he is not college material.

Albertosaurus

Nathan Cook said...

This move by the FDA would be a natural consequence of the Genetic Information Nondiscrimination Act. That Act prohibited insurers and employers from using genetic information, a restriction that has had little practical effect until now, but will eventually lead to adverse selection as the price of genetic sequencing falls and the informativeness rises. Eventually one of three things will happen: insurance prices will rise sharply, the Act will be repealed or amended, or accessing your genome will be made costly or difficult. Having to post a swab to a foreign country is probably enough of a bar that the insurance industry can carry on as normal.

spacehabitats said...

As a physician I couldn't agree more with Harpending. The medical profession has no universal right to withhold important information from our own patients, let alone all of the citizens of the United States.

The AMA is notorious for NOT speaking for its members or even representing their best interests. (BTW, I am NOT a member of the AMA and episodes like this only make me less likely to join.)

I disagree with Bill. He is correct in recognizing that paternity is the most important and immediate market for personal genetic testing. But it is not the loss of an economic windfall that is causing resistance by the AMA. I think they are responding to the politically explosive potential of a population made genetically aware.

Ultimately it is linked to the conspiracy to suppress sociobiology, IQ testing, race awareness, and all non-politically correct speech or thought.

Our current political establishment is built upon a theocratic state whose policies and premises fly in the face of any type of scientific reality. Whether it is the "perpetual motion machine" of Keynesian economics, or the "flat earth" world view behind the tabula rasa social theories; the insiders depend upon mass ignorance to justify their policies and perpetuate their status.

Svigor said...

I have absolutely no doubt that the primary role of genetic testing will be to establish paternity in the near future.

Nah, you forgot screening embryos. That's a much bigger potential market.

Geoff Matthews said...

Nanonymous,

We Utes tend to be more numerate.

none of the above said...

Assuming there's some reason for this other than guild protection or grabbing of bureaucratic turf, it's presumably because of fears of what will become visible in these tests in the future. Right now, I think a normal person who sends in a DNA sample is very unlikely to learn anything very important about his health or intelligence. Perhaps this will change over time, though I think if it does change, it pretty much has to involve multiple genes interacting. But my guess is that there isn't a good reason for it, and we're in the realm of "let's make sure the doctors get a cut of this market."

Henry Harpending said...

@JZ:

No argument about patients' knowledge of Bayes Theorem, and I am sure you are right about many or most patients wanting paternalism. But health prediction is a small part of the demand for DTC testing. Most of it is ancestry tracing, I think.

There is a kind of gray area in between. I would if I could have my daughter's boyfriend tested for, among others, the active form of the androgen receptor, or the 7R version of dopamine receptor 4. Not great predictors of his likelihood of sticking around, but not bad either.

I would not get either with SNP chips, of course, but soon...

Henry

pavellas.com said...

It's worse than paternalism. It is part of the continual assault on our liberty by an overweening state. Read "Our Enemy the State" by Albert Jay Nock: http://www.barefootsworld.net/nockoets0.html

John said...

Svigor: "Nah, you forgot screening embryos. That's a much bigger potential market."

I agree with the previous commenter that countering the threat to the political orthodoxy is the main is more a consideration than the pecuniary interests.

But Svigor, you allude to a greater interest. among the would-be gene-priests: with legally and morally (in the current Zeitgeist) acceptable abortion, the possibility of do-it-yourself eugenics that would be hard to denounce and effectively with the "Nazi" smear and take any effective countermeasures against.

John said...

"As a physician I couldn't agree more with Harpending. The medical profession has no universal right to withhold important information from our own patients, let alone all of the citizens of the United States."

They have no "right" to dictate to anyone what drugs they can take or how they may or may not heal themselves, with or without advice or consultation, either -- and they need no such "rights" to do such things.

Garrett Smith said...

I think we can expect our overreaching government to continue to restrict our freedoms. They have deeply regretted allowing internet freedom as its brought a level of freedom of speech and freedom of information back to the public that the elites had been happily squelching for a half century. I expect they will err on the side of caution (from their point of view) more often from now on.

Connor O' Harredin said...

I don't think he's talking about paternity testing here, guys. You can drive down to your local pharmacy and buy your own kit to do that now, without your physician's prescription or knowledge. More likely he is talking having your genome sequenced (either in part or in full) to find out about your personal potential for genetic disorders that potentially could be determined from the results. For example, a specific mutation in a specific gene may increase your chances of having prostate cancer.

My guess is that the company that did the sequencing would provide them with a layman's interpretation when they received their results. If not, as a molecular biologist, I think most people would need to have a professional assist them in interpreting the data. That being said, I think people should have the freedom to do it and decide themselves to hire someone to assist them if they want. Kind of like the situation with taxes- some people find they can wade through the rules and figure it out themselves, others want an accountant.

David said...

Albertosaurus said

>[T]he administration isn't so much afraid of an individual getting a report that says that he has a 3% greater than average risk of heart disease. They fear the report that says that he is not college material.<

Brilliantly stated.