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Archive for November 2011

Science Policy Around the Web – November 28, 2011

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By jeltovski on Morguefile.com. Used with permission

By:  Rebecca Cerio

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Cooking in the Classroom Helps Kids Learn, Changes Food Attitudes – An evaluation of the Cooking with Kids program shows that fruit and vegetable tastings and cooking classes integrated into other core curricula (history, science, etc.) introduces kids to new, healthy foods, changes their views of cooking as “chores”, and helps them understand the curriculum material better.    (via EurekAlert.org)

Congress Blocks New School Lunch Rules – The USDA proposed new rules to make school lunches healthier by increasing fruits and vegetables and decreasing starch and salt.  Critics said that the new proposals were too restrictive and would result in lunches kids wouldn’t eat.  Congress listened.  (via The New York Times, by Ron Nixon)

Debate Intensifies on Usefulness and Ethics of Chimpanzee Research – Is invasive ape research useful?  Is it ethical?  Would a ban on invasive great ape research (such as the Great Ape Protection Act, now in Congress) be an ethical protection of primate species or an unethical roadblock to cures for human disease?   An NIH report due this year on the usefulness of chimps in research will hopefully bring some data to the debate table. (via The New York Times, by James Gorman)

Have an interesting science policy link to share?  Let us know in the comments!

Written by sciencepolicyforall

November 28, 2011 at 10:53 am

Off-label Prescriptions: Patient Protection vs Biomedical Innovation

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Image courtesy of NIH Image Bank

by Brenda Kostelecky

The serendipitous nature of scientific research is well appreciated and many drugs that were developed for one disease have later been found effective in treating other conditions. Examples of such drugs include azidothymidine (AZT), a major breakthrough in HIV/AIDS treatment that was initially developed to combat cancer, and imatinib, which was first approved for treatment of chronic myeloid leukemia and later to combat gastrointestinal stromal tumors. Exploration of additional uses for existing drugs has tremendous potential to benefit patients with conditions that currently lack quality treatments and those patients for whom traditional treatments are available but have failed. There are a number of ways to explore new drug uses, one of which is off-label drug prescriptions. Although the U.S. Food and Drug Administration (FDA) approves new drugs for very specific uses, doctors are allowed to prescribe an FDA approved drug for any additional “off-label” uses. There is some rationale for allowing doctors to prescribe drugs off-label. Patients want access to the best medicines available and doctors want to preserve all possible weapons in their treatment arsenal.

Does the practice of off-label prescribing encourage innovation of beneficial therapies while adequately protecting patients? Policymakers and the FDA continue to grapple with this question and try to ensure scientific evidence informs the use of medical products. Off-label drug use comes with serious concerns. The fact that a physician prescribes a drug conveys the message to patients that its use is scientifically supported. In fact, evidence suggests that approximately 20% of all prescriptions are written for off-label drug uses and that 73% of those uses are supported by little or no scientific evidence. One problem is that given the current speed of research, busy physicians often struggle to stay abreast of the latest available scientific evidence. Corporate motive is also a concern because off-label drug use can be lucrative for pharmaceutical companies and may pit their profits and desire to sustain future drug development efforts against patient protection.

One step the FDA has taken to limit scientifically unsupported drug prescription is to prohibit the direct marketing of drugs to doctors by pharmaceutical companies for off-label uses. Companies are, however, allowed to distribute journal articles supporting off-label drug uses to physicians. Although these articles must be peer-reviewed, they may be limited to very small patient populations, compare the drug only to a placebo when another suitable treatment is available, or be industry-sponsored. In addition, studies reporting positive findings are far more likely to be published than studies finding no effect and may give physicians the false impression that the published data is representative of all trial data.

While there is hot debate about how extensive the FDA’s role should be in both patient protection and innovation, FDA Commissioner Margaret A. Hamburg, M.D., contends that these two objectives need not be at odds with one another. Dr. Hamburg suggests that if the FDA ensures the best drugs – rather than the most effectively marketed drugs – rise to the top, innovations that can truly help patients will be promoted. One potential way the FDA could ensure doctors prescribe treatments based on evidence is to conduct comprehensive evidence analysis and regularly provide educational material to physicians on the current state of scientific research. Greater patient protection could be provided by requiring patients’ informed consent so they are aware of the risks and uncertainty regarding off-label drugs they are prescribed. Greater investment in regulatory science to develop new methods and standards could help speed development and FDA approval of quality medical advances. Some of these mechanisms could underpin a comprehensive approach addressing potential pitfalls to ensure that off-label prescription supports the FDA’s dual goals of true biomedical innovation and patient protection.

References:

(1) Zidovudine (AZT). From Wikipedia. http://en.wikipedia.org/wiki/Zidovudine
(2) Imatinib. From the U.S. National Library of Medicine. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000345/
(3) Regulating Off-Label Drug Use — Rethinking the Role of the FDA. Stafford RS, N Engl J Med 2008; 358:1427-1429. http://www.nejm.org/doi/full/10.1056/NEJMp0802107
(4) Cooking the Books: The statistical games behind “off-label” prescription drug use. Sanghavi D, Slate 2009. http://www.slate.com/articles/news_and_politics/prescriptions/2009/12/cooking_the_books.html
(5) Innovation, Regulation, and the FDA. Hamburg, MA, N Engl J Med 2010;363:2228-32. http://www.nejm.org/doi/pdf/10.1056/NEJMsa1007467

Written by sciencepolicyforall

November 22, 2011 at 2:23 pm

Posted in Essays

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Science Policy Around the Web – November 16, 2011

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By:  Rebecca Cerio

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Alarming Pattern of Antibiotic Use Emerges - Antibiotic use is up, particularly in certain parts of the country like the Southeast.  Is this use responsible, or are we overprescribing antibiotics for illnesses that they cannot treat (like colds and the flu)?  As antibiotic overuse can lead to pathogens developing antibiotic resistance, the Extending the Cure project suggests that the driving forces behind increased antibiotic use should be investigated.  (press release via the Center for Disease Dynamics, Economics & Policy, by Andrea Titus)

Why Science Majors Change Their Minds (It’s Just So Darn Hard) –  “…middle and high school students are having most of the fun, building their erector sets and dropping eggs into water to test the first law of motion. The excitement quickly fades as students brush up against the reality of what David E. Goldberg, an emeritus engineering professor, calls “the math-science death march.” Freshmen in college wade through a blizzard of calculus, physics and chemistry in lecture halls with hundreds of other students. And then many wash out.”  (via The New York Times, by Christopher Drew)

Switching from Intravenous to Oral Medications Can Save Millions – Researchers at Johns Hopkins Hospital found that switching hospitalized patients from an intravenous to an equivalent oral version of just four expensive medications could save over a million dollars a year.  They suggest that widespread education and reminders to doctors to prescribe the cheaper oral form of medications to eligible patients could save billions in health care costs annually. (via Futurity.org, by Stephanie Desmond)


Have an interesting science policy link to share?  Let us know in the comments!

Written by sciencepolicyforall

November 16, 2011 at 12:46 pm

Science Policy Around the Web – November 9, 2011

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Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Regulating Off-Label Drug Use – Off-label drug use (taking a drug for a condition that it is not specifically approved for) accounts for over 20% of prescriptions written.  This practice allows physicians flexibility when a drug can be useful in treating more than its indicated disease, but it can also encourage companies to promote off-label uses that have not been clinically tested.  (via the New England Journal of Medicine, by Randall S. Stafford, M.D., Ph.D)

Dispute Over USDA’s Proposed School Lunch Rules – The USDA has proposed new rules that will make school lunches healthier by increasing fruits and vegetables and decreasing starch and salt.  Critics say that the new proposals are too restrictive and will result in lunches kids won’t eat. (via The New York Times, by Ron Nixon)

Why Science Majors Change Their Minds -  “…middle and high school students are having most of the fun, building their erector sets and dropping eggs into water to test the first law of motion. The excitement quickly fades as students brush up against the reality of what David E. Goldberg, an emeritus engineering professor, calls “the math-science death march.” Freshmen in college wade through a blizzard of calculus, physics and chemistry in lecture halls with hundreds of other students. And then many wash out.”  (via The New York Times, by Christopher Drew)


Have an interesting science policy link to share?  Let us know in the comments!

Written by sciencepolicyforall

November 9, 2011 at 8:35 pm

Synthetic Biology and Biodefense: Regulating the Unknown

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By Rebecca Cerio

The field of synthetic biology–most broadly described as the design and construction of new biological functions and systems not found in nature–has been quietly advancing ever since the discovery of restriction enzymes in the 1970s.  Being able to cut-and-paste DNA segments in combinations different than those created by nature opened the door to molecular biology and the burgeoning biotechnology field.  Such technologies, as well as our understanding of DNA functional and regulatory elements, now allow us to genetically engineer organisms to produce needed medicines, to bioengineer pest- and chemical-resistant food crops, and to sequence and study the genome of any organism for useful and harmful mutations.

Recently, the J. Craig Venter Institute’s announcement that they can chemically synthesize an entire, functional genome in the lab has led to new public awareness of the potential power, benefits, and dangers of synthetic biology.  One question raised is:  just because we can, does that mean that we should?
Or, from a regulatory standpoint, just because it is possible, should it be allowed?  Synthetic biology technology can be used for legitimate scientific purposes (i.e., producing vaccines) and to threaten public safety  (i.e., producing deadly pathogens).  But what are the actual, plausible risks and benefits of synthetic biology, beyond movie-plot scenarios and inflammatory rhetoric about “playing God”? Read the rest of this entry »

Written by sciencepolicyforall

November 4, 2011 at 9:19 am

Posted in Essays

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Science Policy Around the Web – November 2, 2011

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Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Critics’ review unexpectedly supports scientific consensus on global warming – A team of UC Berkeleyphysicists and statisticians that set out to challenge the scientific consensus on global warming is finding that its data-crunching effort is producing results nearly identical to those underlying the prevailing view. The Berkeley Earth Surface Temperature project was launched by physics professor Richard Muller, a longtime critic of government-led climate studies, to address what he called “the legitimate concerns” of skeptics who believe that global warming is exaggerated. (via Los Angeles Times, by Margot Roosevelt)

Baseball commissioner Bud Selig wants ban on chewing tobacco – Always a hidebound sport, baseball has accepted interleague play, the wild card and even video replay in the last 20 years. Now a campaign backed by members of Congress and Commissioner Bud Selig is taking on something that’s been a part of the game’s culture for well over 150 years — chewing tobacco on the field. Public health groups have gained traction with a classic argument: When ballplayers are seen chewing a wad of tobacco or using dip — products collectively known as smokeless tobacco — they set a bad health example for kids who look up to the athletes as role models. (via MassLive.com, by Frederic J. Frommer)

X-Rays No Help Against Lung Cancer – Annual chest X-rays didn’t significantly reduce the death rate from lung cancer in a study involving more than 150,000 patients that reflects the challenges of using early detection to save lives in the battle against malignancies. The findings suggest the best strategy for discovering lung tumors in an early, more treatable stage is screening with more-costly CT scans, which were shown in a separate recent study to lower the death rate by 20% despite a high percentage of false-positive results. (via The Wall Street Journal, by Ron Winslow)

Have an interesting science policy link to share?  Let us know in the comments!

Written by sciencepolicyforall

November 2, 2011 at 6:18 pm

Posted in Linkposts

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