Category: Obesity
Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON
In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year. While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.
The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.
The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Read More
How Coke might help cure obesity
Coca-Cola has an interesting symbolic presence the world of public health.
Its delivery system is the envy of vaccine programs: the committed global health workers who’ve trekked for days through harsh and inhospitable lands to reach even the most distant communities are likely to find a refreshing, cold Coke already waiting for them at the village store.
For those who focus on non-communicable chronic diseases (NCD), (regular) Coke is the scourge that is providing the extra calories that fuels the obesity epidemic. Many experts believe that eliminating the calories contained in a single, 16oz serving of regular Coke from daily diet would be more than enough to revert the trend towards rising obesity and return average weight in the population back to where it was 30 years ago.
But the symbolic presence of Coca-Cola in US culture and politics is perhaps even more interesting, and the resulting dynamics could have some unexpected consequences in terms of population health.
TOMORROW: Second Annual Health Law Year in P/Review
Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.
This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.
The full agenda is available on our website. Speakers are: Read More
1/31: Second Annual Health Law Year in P/Review
Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.
This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.
The full agenda is available on our website. Speakers are: Read More
1/31: Second Annual Health Law Year in P/Review conference
Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.
This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.
The full agenda is available on our website. Speakers are: Read More
DUE MONDAY: Call for Abstracts for Petrie-Flom Center 2014 Annual Conference
The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:
- Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions? What is a “best” decision, i.e., whose perspective should be paramount?
- What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
- Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
- What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa? Where should the nudges push?
- Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture? When nudges are not plausible, what is the best way to overcome bounded rationality?
- When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
- How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
- What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?
Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.
Calls for abstracts are due by December 2, 2013.
For a full conference description, including the call for abstracts and registration information, please visit our website.
DUE IN ONE WEEK: Call for Abstracts for Petrie-Flom Center 2014 Annual Conference
The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:
- Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions? What is a “best” decision, i.e., whose perspective should be paramount?
- What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
- Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
- What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa? Where should the nudges push?
- Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture? When nudges are not plausible, what is the best way to overcome bounded rationality?
- When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
- How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
- What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?
Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.
Abstracts are due by December 2, 2013.
For a full conference description, including the call for abstracts and registration information, please visit our website.
Call for Abstracts, Petrie-Flom Center 2014 Annual Conference
The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:
- Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions? What is a “best” decision, i.e., whose perspective should be paramount?
- What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
- Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
- What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa? Where should the nudges push?
- Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture? When nudges are not plausible, what is the best way to overcome bounded rationality?
- When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
- How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
- What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?
Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.
Abstracts are due by December 2, 2013.
For a full conference description, including the call for abstracts and registration information, please visit our website.
Popular Distrust of Health Science: A Crowdsourced Solution
Enjoying the fall foliage in Mt. Auburn Cemetery yesterday, I came across this marker for Benjamin Waterhouse. In the overwrought language that is appropriate on a grave marker: “In 1800 he introduced to the new world the blessing of vaccination. Overcame popular prejudice and distrust by testing it on his own children and thus established a title to the gratitude of future generations.”
No less today, there seems to be plenty of popular distrust of elite science. (And it doesn’t help that so much of contemporary science is infected by conflicts of interest.) Self-experimentation does have a long venerable history, which has recently become more prominent in the quantified self movement. (I’m not sure about experimenting on my kid though.)
Tomorrow, I’m heading to NYC to make a pitch to the Robert Wood Johnson Foundation’s Pioneer Fund, for major funding to launch a new project that would create a platform for robust, randomized experiments of lifestyle interventions (think: migraine management, diets, exercise regimens, nutritional supplements) for which there is virtually no FDA oversight and thus no regulatory imperative for rigorous scientific investigations. Nonetheless, these lifestyle factors are the primary drivers of health and healthcare costs. By crowdsourcing these sorts of experiments in an sound ethical framework robust against institutional corruption, I hope to develop gold-standard scientific knowledge with huge samples, but also build public engagement, public understanding, and public trust of health science.
The crowd uses Wikipedia to organize knowledge, and Indiegogo to invest in new health devices. The crowd needs a platform to create knowledge too, especially through randomized interventions, which have the potential to actually change behaviors for the better and eliminate the confounding factors that undermine observational studies.
So, wish me luck in NYC tomorrow: https://bit.ly/pioneerpitch
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