Parallel Dataverses: Doppelgangers in Medicine and Recreation

Dr. Egon Spengler: There’s something very important I forgot to tell you.
Dr. Peter Venkman: What?
Dr. Egon Spengler: Don’t cross the streams.
Dr. Peter Venkman: Why?
Dr. Egon Spengler: It would be bad.

Some regulatory regimes in the United States, like those in the state of New York, require laboratories that receive and analyze any tissue specimen for any purpose to adhere to standards of clinical medicine. The laboratories are, for example, required to follow quality measures defined by the Clinical Laboratory Improvement Amendments (CLIA). Furthermore, individual citizens are prohibited from ordering laboratory services directly. They must, instead, work through a state-appointed and licensed physician if they seek to obtain personal biological data.

This restriction does not depend on the intended use of the data. An individual who wants to have the DNA in their saliva analyzed for recreational purposes, like genealogy or ancestry or education, still must work through a physician.

This has resulted in the paradoxical situation of non-clinical, clinical genetic testing. “Don’t cross the streams,” Dr. Egon Spengler would say. Well, the streams are already crossed and its time, I think, to uncross them. Biological data for non-medical purposes needs a paradigm distinct from the medical domain.

Here are a few reasons why this proposal should be strongly considered:

(1) Physicians are overburdened as it is, there is no need from them to be involved in recreational activities like genetic genealogy.

(2) Ditto for governmental regulatory bodies that are charged with ensuring the quality and safety of medical products and practices.

(3) Autonomy of individuals is being restricted unjustly.

(4) Enforcing clinical standards on non-clinical activities puts an unfair burden on individuals who may want to specifically avoid clinical implications of genetic sequence data, which might include the discovery of a medically relevant genotype (e.g., male infertility and genealogy testing) and health insurance liabilities.

So, what do you think? Should uncrossing the streams be an initiative we support? What are other reasons why this may or may not be a good idea?

Private Little Revolutions

Best sentence I read today:

"The doctor-patient relationship hinges on informed consent, but the FDA says only a doctor may do some of the informing."

Peter Huber is referring specifically to the informing that is done via diagnostic testing such as pregnancy testing, HIV testing, genetic testing, and innumerable other blood/urine/tissue testing.  Diagnostic testing is a means of extracting and communicating information about personal biology.  Diagnostics are informational devices. 

Some believe there are forms of your personal biological information that you should NOT have access to, or at least access should be complicated to achieve.  AND if you do manage to get access, this information should only be dispensed in a professional setting (i.e. a clinic).  Huber’s thesis:

"Diagnostic technology is on a collision course with the FDA.  A dipstick (or something much like one) is coming to diagnose just about anything: infectious disease, disease caused by your own cells gone haywire or the threat of disease caused by imperfect genes…If the FDA will allow it…"

Some diagnostic tests, like the pregnancy test, have successfully passed through the regulatory gauntlet, and have become, in limited circumstances, common fixtures of drug store shelves, internet commerce, and even home use.

While difficult to imagine, pregnancy testing was once only allowed through a physician.  Today nearly one-third of all U.S. women have taken a home pregnancy test.  In the early part of the 20th century, there were technological barriers to home pregnancy testing — diagnosing pregnancy involved injecting rabbits with a woman’s urine, i.e. the Rabbit Test.  By the late 1970s, once the technology to diagnose pregnancy had been improved and simplified, a different kind of barrier arose: social barriers.  As historian Sarah Leavitt  has recently documented, Consumer Reports in 1978 was no fan of the home pregnancy test:

…the need for an early pregnancy test was seen as evidence of promiscuity. A state health official told the magazine: “there is no reason for a woman in Maryland to buy a kit such as the EPT unless she doesn’t want to be seen at the health department.”  The suggestion that only immoral women with something to hide would need a home test kit led the magazine to conclude that “even if it is used correctly, the EPT appears to be a needless purchase” for its readers.  The editors recommended that women visit their doctor or a clinic to get results instead—but women found ways around these strictures and increasingly demanded access to private, personal, informed, and nonjudgmental health care, of which the pregnancy test was a part.

Consumer Reports has since changed its tune of course.  Twenty years after its original article, inuendos of the immoral nature of home testing had been dropped (they had follow-up articles in 1996 and 2003).

Lynch_clearblueeasy

Caption: Did you know that David Lynch directed an
advertisement for the home preganancy test Clear Blue Easy?

Sarah Leavitt beautifully summarizes the impact of the home pregnancy test:

Women in this generation who take home pregnancy tests are able to know something about themselves and their futures in a time frame that was simply not possible for their grandmothers, or even their mothers.  The kit modified the network of actors involved in diagnosing pregnancy, taking the event from the doctor’s office to the home. It has also modified the time frame of pregnancy by reconfiguring the original discovery. Its revolutionary status, therefore, is small but personal, removing the moment of pregnancy diagnosis from the institutional gaze of the doctor to the private gaze of the pregnant (or not-pregnant) woman herself. It is an example of the way in which the women’s health movement worked to recapture women’s control over much information related to pregnancy.

If Peter Huber’s thesis is correct, there is a similar need for "private little revolutions" in other aspects of health care, a need to recapture control over other forms of personal biological information.

Peter Huber. The Patient’s Right to Know. Forbes.  07.24.06

Sarah A. Leavitt "A Private Little Revolution": The Home Pregnancy Test in American Culture. Bulletin of the History of Medicine 80.2 (2006) 317-345. (sorry subscribers only)

CHECK OUT Sarah Leavitt’s exhibit: "A Thin Blue Line: A History of the Pregnancy Test Kit"

For more on DAT, see Bruce Friedman’s post and the links within.