The Daily Dose – Retirement for Ronald?

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— Scientists argue for increased openness by the European Medicines Agency (EMA) in a BMJ commentary published yesterday. The authors write that secrecy over trial data, such as that submitted for the flu drug oseltamivir (better known as Tamiflu), “implies undue exploitation of the rights of doctors and patients participating in the studies,” and the data should be made public for outside analysis. (ScienceDaily)

— Amphastar Pharmaceuticals took a controversial approach toward ensuring one of its products would be approved: The company reportedly hired a private investigator to follow Janet Woodcock, director of the US Food and Drug Administration’s Center for Drug Evaluation and Research. Believing she had conflicts of interest against their drug, Amphastar pursued Woodcock’s phone records and other public documents. In February, an FDA legal counsel said that Woodcock had no conflict of interest. (Pharmalot)

— The synthetic estrogen drug Raloxifene might help treat schizophrenia, according to preliminary research. A dosage study found that the drug, which is currently used for osteoporosis, significantly sped up recovery from schizophrenia symptoms among postmenopausal women. (ScienceDaily)

Ronald McDonald might need a Happy Meal to improve his mood. A watchdog group, Corporate Accountability International (CAI), is asking McDonalds to retire the clown because he promotes unhealthy eating among children. Drawing on another famous mascot, CAI called Ronald a “deep-fried Joe Camel for [the] 21st century.” (CNN)

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The Daily Dose – Myriad’s hold on BRCA broken

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— A US district judge rejected patents on the BRCA1 and BRCA2 breast cancer genes yesterday. The American Civil Liberties Union (ACLU) sued patent owner Myriad Genetics in May, and the judge agreed with ACLU claims, writing that the “isolated DNA is not markedly different from native DNA as it exists in nature” and the “sequences are abstract mental processes,” making them unpatentable. (Reuters)

— The UK government will soon add the ‘legal high’ mephedrone, which has been linked to several deaths in the country, to its list of illegal drugs. Following on a recommendation by the Advisory Council on Misuse of Drugs, UK home secretary Alan Johnson has decided to list mephedrone as Class B, on level with cannabis. (BBC)

— Scientists warn that the bacteria causing gonorrhea, a sexually transmitted infection, are rapidly developing resistance to the two antibiotics most frequently prescribed. With resistant strains seen in Hong Kong, Japan, and Australia, the World Health Organization is expected to discuss treatment strategies at a meeting next week. (Reuters)

— The efficacy of stroke treatments in animals might be overestimated, according to researchers. Because of publication bias, which selects for studies reporting positive findings, the study authors estimate that the 31% efficacy seen in reviewing published findings might be lowered to just 24% with unpublished data. In other research, scientists note that an imbalance toward using male mice is biasing research. (Science)

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Paving a better path to healthcare science

Healthcare Science Week’ may have just ended, but the discussion of careers in this area will continue. That’s in part because the UK’s Department of Health introduced a new framework in Februrary to modernize career pathways and training for those entering or already within the field of healthcare science.

In Britain, healthcare scientists work within a range of approximately 50 disciplines in the life sciences, physiological sciences and clinical engineering and physical sciences. These scientists work primarily toward providing expert diagnostic advice and therapy for patient care and prevention of disease. A healthcare scientist in the UK can vary from being a hospital pharmacist to being a clinical geneticist or a cardiographer.

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Tanning is a drag

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For decades, celebrities helped make smoking glamorous, so much so that filmmakers made a movie about it. Cigarettes were the stuff of romance, but as research found in the latter part of the 20th century, cigarettes were also the stuff of cancer. Today, history is repeating itself, as the bright lights of scrutiny have a new focus: indoor tanning.

After years of celebrity following, tanning, too, is developing a reputation as a carcinogen. Parents and many others are concerned, and last week, the US Food and Drug Administration (FDA) held a hearing to discuss the issue. Panel members considered nationalizing a law, already enacted by several states, that requires parental permission for minors, but a 2008 study found such laws had no significant influence on teenage tanning rates between 1998 and 2004. Thursday’s panel instead recommended an outright ban for minors, which it will soon present to the FDA.

There’s plenty other research to back the claims that tanning beds are highly carcinogenic. A 2003 study found that women ages 20-29 who tanned indoors at least once a month had two-and-a-half times the risk of developing melanoma. In 2007, the World Health Organization (WHO) conducted a review and estimated that tanning bed exposure before age 35 increased melanoma risk by 75%. Two years later, the WHO deemed tanning a carcinogen on par with asbestos and — you guessed it — cigarettes.

The similarities don’t end there, of course. According to a recent study, the advertising strategies of the tanning and smoking industries share eerie similarities: both have claimed that research on safety is exaggerated, featured doctors as supporters, and pushed ‘healthier’ versions of their products. Resistance, however, is growing. In January members of Congress introduced a more stringent ‘Tanning Bed Cancer Control Act’ that would increase federal oversight. And last week saw the passage of a 10% federal ‘sin’ tax on indoor tanning.

Only time will tell, though, if the nation’s youth make the same mistakes as their parents and grandparents did with cigarettes, ignoring the research while they instead admire their (literally) golden idols. The cast of ‘Jersey Shore,’ for example, has popularized the “GTL” mantra (for the uninitiated, that’s “Gym. Tan. Laundry.”) We can only hope that — like the show — it doesn’t stick around too long.

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VIDEO: Marker for MS may lead to treatment options

A new blood test seems able to parse whether beta-interferon — the major treatment for multiple sclerosis (MS) — will work for MS patients even before therapy begins. Reporting online yesterday in Nature Medicine, a team led by Larry Steinman, a neurologist at Stanford University, found that the efficacy of the $25,000 per year drug depends on what immune cell type is involved in the disease.

“Now we have the realistic prospect that we could have a test that will tell us whether beta-interferon will work in a person with MS,” says Steinman, who explains the findings in the following video:

Other coverage:

MS study may have treatment implications (Globe and Mail)

Discovery may lead to better multiple sclerosis treatments (Business Week)

<A HREF=“https://pagingdrgupta.blogs.cnn.com/2010/03/29/scientists-find-there-may-be-two-forms-of-multiple-sclerosis/”>Scientists find there may be two forms of multiple sclerosis (CNN)

”https://voices.washingtonpost.com/checkup/2010/03/are_there_multiple_forms_of_ms.html?wprss=checkup">Multiple forms of MS? (Washington Post)

Test predicts which patients benefit from $6 dillion MS drugs (Bloomberg)

The Daily Dose – Give your health a ring

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— The health care protestor who was caught on video heckling a man with Parkinson’s disease (see our post here) apologized last week. Christopher Reichert, of Ohio, initially denied verbally assailing and throwing dollar bills at Robert Letcher, a former nuclear engineer who held a sign in support of health care reform. Reichert reportedly now admits, however, that he “snapped,” and vows to never attend another political rally. (Columbus Dispatch)

— Researchers have determined the structure of a key binding region in the insulin receptor. A previous study had yielded the overall conformation, but discovery of the insulin binding site might lead to diabetes treatments that better target the receptor. (ScienceDaily)

— Teva, the world’s largest generic drug maker, gave big pharma firms a run for their money during the year ending September 2009. The Israeli company was No. 1 in terms of rising revenues with a 12.3% growth rate; revenues surged to $15.7 billion, putting the company at No. 11 on the list of the world’s top drug makers (FiercePharma). For more on Teva, check out our Q&A with chief executive Shlomo Yanai in this month’s issue of Nature Medicine.

— If your phone makes you jump a little every time it rings, you may be surprised by the latest craze in Japan: therapeutic ring tones. The Japan Ringing Tone Laboratory claims its jingles can, for example, help those trying to diet, or dislodge pollen from the noses of allergy sufferers. For some science-minded folks, however, it may not hit all the right notes. (BBC)

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The Daily Dose – Friday flashback

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Before you head off for the weekend, let’s take a look back at a few of the stories we’ve covered recently, and give you a few updates:

— With the passage of US health care reform, you’re probably wondering which provisions actually made it through. Well, among the survivors is a $500 million National Institutes of Health program that will fund research on new therapies. The ‘Cure Accelerations Network’, which we highlighted in February, will distribute individual grants of up to $15 million a year, and work in close coordination with the US Food and Drug Administration to ensure that therapies make it to market sooner.

— A new initiative for comparative effectiveness research also came through in the health care bill. The $500 million institute will be created to oversee all such research, which compares one treatment to another, as well as determine how the results are applied to practice.

— Lastly among the health care updates, the legislation ended up allowing 12 years of data exclusivity for new biologics. Some had hoped these therapies, which are derived from living cells, would be given only five years of exclusivity before cheaper generics enter the market.

— Algae is blooming: Our February feature described how green algae can replace mammalian cells to produce therapeutic human proteins. Now, Stephen Mayfield, director of the San Diego Center for Algae Biotechnology, reports that among seven proteins he derived from genetically modified algae, four proteins were produced at levels suitable for commercial use.

— In this month’s issue we feature new rat models of disease, as well as the battle over stem cell patents. Those two topics came together last week, when the UK Intellectual Property Office granted StemCells, Inc. a patent on rat pluripotent stem cells, as well as any genetically modified rats derived from those cells.

— Finally, the UK is looking to combat a downward trend in clinical trials, as we discussed in last month’s issue. And yesterday, the country’s secretary of state for health, Andrew Burnham, announced that the Academy of Medical Sciences would conduct a review of government regulations that might be hindering research.

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The Daily Dose – The Andrew Jackson cure for cancer

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— Ads soliciting US college egg donors are going too far with compensation, according to a new report. The researcher analyzed 105 student newspaper advertisements, finding that 23% offered more than $10,000. That amount violates guidelines from the American Society for Reproductive Medicine, but in an accompanying editorial, an ASRM member argues that little can be done, by the professional group or US government, in terms of policing. (LATimes)

— China might now be the world leader in diabetes. A new survey estimates that 92 million Chinese are living with the disease, a rate of almost 1 in 10 for the world’s most populous country. Now in second place, India has an estimated 50 million diabetics. (Reuters)

— A breast cancer cure is just $20 — and a few years — away, according to Andrew Hessel, a former research manager with Amgen. Hessel has started the Pink Army Cooperative, an initiative to search for a personalized cure for breast cancer. Those who join the cooperative by purchasing a $20 share will be given access to the cure, if and when it comes. (NYTimes)

— Americans with chronic disease are more likely to participate in social networking sites, discussion forums, and blogs regarding health, according to a new report. Though they’re 19% less likely to have internet access, such patients seek out the comfort and advice of others (NYTimes). Doctors warn, however, against trusting online sources, noting that “[f]alsehoods are easily and rapidly propagated on the Internet” in an NEJM commentary published today. (ScienceDaily)

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The unhealthy side of health care reform

The health care bill passed this week in the US House was meant to serve as a Band-aid for a country in which millions of people have lived for decades without basic medical assistance. But the debate leading up to Sunday night’s vote seems to have rehashed old wounds rather than heal them. On Saturday, protesters in the nation’s capital spat on a black congressman and shouted racial and homophobic slurs at a few other lawmakers.

At another rally last week in Columbus, Ohio, opponents of health reform taunted a man with Parkinson’s disease. The event was caught on film.

Bob, the man with Parkinson’s, later responded to the scorn he faced.

For the health of nation, let’s hope that a cure is found for such disrespectful behavior.

For more coverage from Nature Medicine about the lead-up to the health care debate, you can take a look back at the following stories:

· ‘Cure acceleration’ funds woven into health reform legislation

· Value of health interventions underestimated by governments

· Straight talk with…Christopher Murray, head of the Institute for Health Metrics and Evaluation at the University of Washington.

The Daily Dose – Life expectancy, liberty, and the pursuit of happiness

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— Bring in the enforcements: The US Food and Drug Administration (FDA) might soon have third-party inspectors monitoring Genzyme’s factory in Allston, Massachusetts. After a few manufacturing problems at the company, the FDA might issue a consent decree, establishing an inspectorate to oversee quality control. (FiercePharma)

— Are we there yet? No, wait a little longer. According to a review of clinical trials, those that are stopped early — often because the benefits of treatment are already seen — underestimate a given treatment’s risks. Study authors compared 91 shortened trials with more than 400 trials that ran their full course, and found that truncated trials underestimate relative risk by 29%, on average.

— Researchers have looked at stratified segments of the US population such as ‘black middle America’ and ‘Northland low-income rural whites’ to get a better picture of life expectancy. According to the study, southern rural blacks seem most affected by the four risk factors analyzed: smoking, high blood pressure, high blood sugar, and high body fat.

— A little test, come too late? The FDA has approved IntelligentMDx’s molecular diagnostic test for H1N1, which the company claims is the first of its kind to make it through. The approval, however, comes under emergency authorization, and the pandemic’s emergency status is set to expire April 26, according to the Cambridge, Massachusetts-based company. (Xconomy)

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