Esther Dyson on the Digital Health Revolution

Scribe Media’s Peter Cervieri interviews Esther Dyson, board member of 23andMe and one of the PGP-10.

Esther Dyson Video Scribe Media

In the interview, Esther gives her views on the history of commerce on the internet, problems with health care as we know it in the U.S., and the future of genetics.

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).


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.

In a Home Near You Soon: DIY Tests for Nearly Everything?

More and more do-it-yourself (DIY) medical tests are coming down the pike.  This week A DIY home HIV test will be reviewed by the FDA’s Blood Products Advisory Committee, they are expected to give guidance on potential OTC status for the OraQuick Advance test on November 3.  The manufacturer, Orasure Technology, currently sells the kits to clinics and doctors for less than $20 each.

This past week, scientists from the Morgagni-Pierantoni Hospital in Forli, Italy published a paper in JAMA demonstrating efficacy of a urine test for bladder cancer.

Maria Aurora Sanchini et al. "Relevance of Urine Telomerase in the Diagnosis of Bladder Cancer" JAMA Vol. 294 No. 16, October 26, 2005.

Bernard M. Branson, MD. "Home Sample Collection Tests for HIV Infection" JAMA. 1998; 280:1699-1701.


Consumers: Cost of Health Care?

Medical consumerism fact of the day:

While consumers can guess the price of a new Honda Accord within $300,
those surveyed were off by $8,100 in their price estimations for a
four-day hospital stay.

Just exactly how much does it cost for a day in the hospital?

Read more

Free Electronic Health Record

Last week a new electronic health record service, iHealthRecord, was launched by Medem Inc. and it is being made available to medical consumers for free.  See a webcast of the launch, which includes a nice talk by Newt Gingrich towards the end (including a pitch for incorporating Medline driven information prescriptions into the service).

A recent article in the the Washington Post described the offerings of for-fee electronic health record providers that sell direct to consumer, including Laxor, FollowMe, WebMD, CapMed, and VitalVault.

Where’s Google?  Esther Dyson has been pushing the idea (or here) that Google should get into the game–I wholeheartedly agree.

DNA Direct Offers Genetic Testing Direct to Consumer

San Francisco based DNA Direct began offering genetic testing services direct to consumer (DTC) in early October.  You may remember that DNA Direct was introduced on this blog back in March, in reference to a New York Times article on DTC genetic testing.   

Currently DNA Direct offers genetic testing services for inherited blood clotting disorders and plans to offer testing services for other conditions in the future. 

Here is a summary of the testing process (see here), as outlined on their excellent webpage:  The decision to test is made by a medical consumer, perhaps with the aid of a risk assessment questionnaire offered free on their website.  A cheek swab kit is mailed to the person, swabbing ensues, and the kit is mailed to a lab for analysis.  A ten chapter personal report is made available via the web.  It contains the results of the test and descriptions of how to understand the results in relation to risks, lifestyle, family, and healthcare.  DNA Direct also provides genetic counseling services over the phone.

In a recent press release, CEO Ryan Phelan discusses her motivation for founding DNA Direct:

“At DNA Direct, we believe that testing is about empowerment - your body and your health are ultimately your responsibility, and your genes offer tremendous insight into personal, medical and lifestyle choices…Genes are a valuable part of the equation, and they must be interpreted in context and in privacy. We have set up a unique service that does just that – while providing individuals with knowledge and insight to take control of their personal health.”

DNA Direct

DNA Direct, "Lifestyle & Heredity: Genetic Test Helps Individuals Evaluate and Reduce Blood Clot Risk", Yahoo! Oct 13, 2004.

Naomi Freundlich, "Genetic Predictions: Just a Swab Away." NYT March 21, 2004.

GeneClinics: Factor V Leiden Thrombophilia

KU Medical Center: Factor V Leiden Thrombophilia

Hitting the 15 minute target: MinuteClinic

MinuteClinic.  You must like the sound of that.  In and out and fifteen minutes?  One can only hope this isn’t just marketing hype.  Coming to a Target near you?  Maybe.

Genetic screening for the benefits of exercise

An example of a genetic test intended to help medical consumers make lifestyle choices appears to have emerged.  According to this press release, BodyMedia has negotiated an exclusive license to genetic technologies based on research “investigating what a person’s genes say about how much their health can benefit from a moderate exercise program.”  This research has been led by Dr. James M. Hagberg of University of Maryland (nice biography here, scroll down; publications here).  Dr. Hagberg’s “team has identified genetic markers that predict particularly significant exercise benefits for patients with a variety of conditions, including high cholesterol, hypertension, diabetes, osteoporosis, and obesity.”  According to an article in the Pittsburgh Business Times, BodyMedia “will integrate the university’s genetics-based guidance with its health-monitoring products.”   

Consumer-Driven Health Care

Regina Herzlinger is convinced that markets are the key to providing medical consumers what they need: choice, control, and information (CCI).  She is the editor of a new collection of papers entitled Consumer-Driven Health Care: Implications for Providers, Players, and Policy-Makers (Amazon shows publication date to be April 9th).  This book (which I have neither read nor received in the mail yet) promises to update and expand the vision she described in her last book Market-Driven Healthcare (1997).

Here is a recent interview with Herzlinger:
Richard L. Reece M.D. "Herzlinger: From Market-Driven to Consumer-Driven Healthcare" HealthLeaders Magazine. March 15 2004.

Consumer Controlled Privacy

Given the fragmentation of medical care and medical records among many healthcare providers, it is essential that consumers have control over this information and the ability to bring it to the attention of their healthcare providers. Moreover, empowering consumers with responsibility for their own genetic information would resolve difficult issues regarding privacy by enabling each individual to determine what level of privacy is appropriate for him or her. Many individuals may choose to have personal genetic information incorporated in their medical records or used for research, thus accepting any attendant risks to privacy. Others may choose to keep this information confidential or release it selectively when it impacts their healthcare…A model that empowers consumers with confidential knowledge of their own genome and the ability to make informed decisions concerning their healthcare represents the ultimate expression of a truly personalized medicine. It is also an effective strategy for circumventing the inadequate infrastructure for genomic services, improving the quality of care, and strengthening protections for individual privacy and autonomy.

Fred Ledley. "A consumer charter for genomic services." Nature Biotechnology. 20(8): 767. (August 2002)

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