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Kamis, 28 Juni 2012
New Study: Is a Calorie a Calorie?
A new study in JAMA led by Dr. Cara B. Ebbeling and colleagues purports to challenge the idea that all calories are equally fattening (1). Let's have a look. When thinking about the role of calorie intake in body fatness, there are basically three camps:
1. Calories don’t matter at all, only diet composition matters.
2. Calories are the only thing that matters, and diet composition is irrelevant.
3. Calories matter, but diet composition may also play a role.
The first one is an odd position that is not very well populated. The second one has a lot of adherents in the research world, and there’s enough evidence to make a good case for it. It’s represented by the phrase ‘a calorie is a calorie’, i.e. all calories are equally fattening. #1 and #2 are both extreme positions, and as such they get a lot of attention. But the third group, although less vocal, may be closest to the truth.
Read more »
1. Calories don’t matter at all, only diet composition matters.
2. Calories are the only thing that matters, and diet composition is irrelevant.
3. Calories matter, but diet composition may also play a role.
The first one is an odd position that is not very well populated. The second one has a lot of adherents in the research world, and there’s enough evidence to make a good case for it. It’s represented by the phrase ‘a calorie is a calorie’, i.e. all calories are equally fattening. #1 and #2 are both extreme positions, and as such they get a lot of attention. But the third group, although less vocal, may be closest to the truth.
Read more »
A Modest Proposal for Peer Review Research
With the advent of, and inexpensive nature of online sharing of information, I propose that all peer-review research should include (anonymous) raw data for each subject. At the very least, there should be scatter plots presented for the individual data points for the main outcomes.
I frequently teach statistics, and one of the first things we discuss in that class is sort of the "first purpose" of it all. Because before we can analyze data, first we must summarize and present the data in such a way that the "consumer" can readily glean information. In one classic stats text -- Triola -- this part is given the acronym CVDOT. C = Center, V = Variation, D = Distribution, O = Outliers and T = Time. So we go through the various ways we can convey the center of a data set, it's variability, distribution, etc. In most of the studies we discuss here, data is presented as a mean value +/- either the standard deviation or standard error (C +/- V in the acronym). And further statistical analysis compares these means between groups for statistically significant differences. If I have 20 subjects in a study, I can provide you with a table of all results sorted by subject number assigned randomly. This tells you very little. If all I do is sort the data ascending or descending, you can now readily pick out the range and "center" of the data. Perhaps if data is of a more rounded nature, you might be able to pick out the most frequent or common values. Outliers will jump off the page.
Read more »Health Care (Insurance) Reform Upheld, but Concentration and Abuse of Power Remain Largely Unaddressed
This may seem like sour grapes, but... Numerous media reports say that the US Supreme Court has upheld the massive US health care "reform" law (look here for Reuters coverage today, and here, for the Los Angeles Times, for example). In my humble opinion, the law will likely increase acess to commercial health care insurance, although will likely not reduce the expense of such insurance, or address the misbehavior of many large insurance companies (for example, see our series of posts on Aetna, UnitedHealth, WellPoint, and the insurance industry in general, etc, etc).
The law, as we summarized here, does contain a few provisions relevant to the concerns we raise on Health Care Renewal. These include measures to improve disclosure of certain kinds of conflicts of interest affecting individual physicians and health care academics, and improved funding for comparative effectiveness research. We hoped that the law would lead to a more rational way to fix payments to physicians that might supplant the secretive, procedure-happy RUC, but so far that hope remains unfulfilled.
However, as we wrote in 2010, the legislation will leave most of the other problems we discuss on Health Care Renewal untouched. We thus have one or two small steps for mankind in the US, but no reason for complacency.
The news is not bad. We are probably on balance somewhat better off with some health care insurance reform than none. However, we are still a long way from meaningfully addressing concentration and abuse of power in health care. There will be no rest for the weary bloggers of Health Care Renewal.
The law, as we summarized here, does contain a few provisions relevant to the concerns we raise on Health Care Renewal. These include measures to improve disclosure of certain kinds of conflicts of interest affecting individual physicians and health care academics, and improved funding for comparative effectiveness research. We hoped that the law would lead to a more rational way to fix payments to physicians that might supplant the secretive, procedure-happy RUC, but so far that hope remains unfulfilled.
However, as we wrote in 2010, the legislation will leave most of the other problems we discuss on Health Care Renewal untouched. We thus have one or two small steps for mankind in the US, but no reason for complacency.
The news is not bad. We are probably on balance somewhat better off with some health care insurance reform than none. However, we are still a long way from meaningfully addressing concentration and abuse of power in health care. There will be no rest for the weary bloggers of Health Care Renewal.
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FDA Safety and Innovation Act: To contain an "Appropriate, risk-based regulatory framework pertaining to health information technology"
Congress has just released an an Act "to amend the Federal Food, Drug, and Cosmetic (FD&C) Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish userfee programs for generic drugs and biosimilars, and for other purposes." Health IT provisions are included.
This Act, S. 3187, is entitled the ‘‘Food and Drug Administration Safety and Innovation Act.’’ PDF fulltext is located at this link: http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf
With regard to health IT, the Act states the following. A risk-based regulatory framework pertaining to health IT is to be developed (emphases mine):
While a welcome development, it is to be determined if the Working Group representatives will include critical thinkers without conflict of interest, whose contributions to the health IT debate in this country are needed a lot more than the traditional hyper-enthusiasts, industry courtiers and opportunists.
I am actually not hopeful.
The "promotes innovation" and "avoids regulatory duplication" phrases are of especially great concern. As I've written before, "innovation" that involves non-consented experimentation is not innovation at all, it is exploitation, and "regulatory duplication" can become an excuse for milquetoast regulation by the conflicted (e.g., regulatory capture) or poorly qualified.
I also note that this Act, while welcome, is long overdue - another example of putting the cart before the horse (link), with a national project (including CMS penalties for non-adopters) now several years underway.
Final thought: if health IT were safe as has been claimed now for decades, or had been made safe through proper development and clinical trials-based testing, we would not need health IT provisions in a "Food and Drug Administration Safety and Innovation Act" in 2012.
-- SS
This Act, S. 3187, is entitled the ‘‘Food and Drug Administration Safety and Innovation Act.’’ PDF fulltext is located at this link: http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf
With regard to health IT, the Act states the following. A risk-based regulatory framework pertaining to health IT is to be developed (emphases mine):
SEC. 618. HEALTH INFORMATION TECHNOLOGY.(a) REPORT.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Commissioner of Food and Drugs, and in consultation with the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission, shall post on the Internet Web sites of the Food and Drug Administration, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology, a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.(b) WORKING GROUP.—(1) IN GENERAL.—In carrying out subsection (a), the Secretary may convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report under subsection (a).(2) REPRESENTATIVES.—If the Secretary convenes the working group under paragraph (1), the Secretary, in consultation with the Commissioner of Food and Drugs, the National Coordinator for Health Information Technology, and the Chairman of the Federal Communications Commission, shall determine the number of representatives participating in the working group, and shall, to the extent practicable, ensure that the working group is geographically diverse and includes representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary.
While a welcome development, it is to be determined if the Working Group representatives will include critical thinkers without conflict of interest, whose contributions to the health IT debate in this country are needed a lot more than the traditional hyper-enthusiasts, industry courtiers and opportunists.
I am actually not hopeful.
The "promotes innovation" and "avoids regulatory duplication" phrases are of especially great concern. As I've written before, "innovation" that involves non-consented experimentation is not innovation at all, it is exploitation, and "regulatory duplication" can become an excuse for milquetoast regulation by the conflicted (e.g., regulatory capture) or poorly qualified.
I also note that this Act, while welcome, is long overdue - another example of putting the cart before the horse (link), with a national project (including CMS penalties for non-adopters) now several years underway.
Final thought: if health IT were safe as has been claimed now for decades, or had been made safe through proper development and clinical trials-based testing, we would not need health IT provisions in a "Food and Drug Administration Safety and Innovation Act" in 2012.
-- SS
Review & Critique: The Skinny on Obesity ~ Part III Hormones
Previously I've shared my thoughts on Episode I and Episode II in this series. This third installment in the series is essentially Lustig's version of Adiposity 101.
The video opens with an adamant Lustig declaring that weight management can't be done by eating less and moving more. It's not doable. Sigh. I think at least the vast majority of NWCR members will disagree. But in any case ...
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